Hair Transplant Practice Guidelines

HAIR TRANSPLANT PRACTICE GUIDELINES: PART 1

Introduction, Rationale, and Scope for the Guidelines:

The field of hair transplant (HT) has grown exponentially in the past decade, especially after the introduction of follicular unit excision. There is much variation in criteria for case selection, the technique, and pre-procedure and post-procedure protocols, by different surgeons. Techniques continue to evolve and evidence in the form of controlled data is not available for all techniques and protocols being used; there is also a debate as to who can do what, what should be the training for staff, and the role of technicians. This has led to a situation wherein medicolegal issues have cropped up as to what is minimum acceptable. An attempt is made here to summarize standard protocols with the available evidence.

It is emphasized that the objective of these guidelines is to recommend minimum standards for practice of HT. The principles outlined in these guidelines are of a general nature only, minimal in their level and are not meant to cover all situations. It should be understood that these recommendations are by no means binding and universal, represent minimum standards only and as in all surgical techniques, variations in techniques are possible. It is also further clarified that these are based on current literature, and as science evolves, these guidelines could also change in future. Where published evidence is not available, consensus expert opinion is presented.

The taskforce emphasizes that each patient has to be treated on his/her own merit and that these guidelines do not limit the physician from making an appropriate choice or the necessary innovation for a given patient. The taskforce recognizes that the treating surgeon is best suited to decide what is needed for a given patient in a given situation. Innovations in medicine need flexibility in approach and these guidelines do not limit the surgeon from undertaking innovative research.

EVIDENCE LEVELS AND LEVELS OF RECOMMENDATION

The taskforce used a modified Harbour and Miller’s revised grading system for recommendations in formulating these guidelines.

PHYSICIAN QUALIFICATIONS, ROLE OF TECHNICIANS, AND TRAINING OF DOCTORS AND STAFF

ROLE OF ASSISTANTS (TECHNICIANS)

HT practice needs assistants, who are also called HT technicians; it is both ethical and necessary that such assistants are from a medical background, such as nurses, lab technicians, pharmacists, and MBBS doctors. However, they need to be provided structured, systematic, and proper training in aspects of both HT and disinfection, sterilization, patient communication etc. However, unrelated nonmedical personnel such as arts graduates, industrial training institute technicians should not be used as they have little understanding of sterilization and cannot handle any medical emergency that may arise during the procedure.

Technicians can be involved only in the following steps of the HT surgery:

• (a)

  Picking up the grafts (extraction) after scoring

• (b)

  Arranging the grafts

• (c)

  Implantation into premade slits

• (d)

  Postoperative dressings

Surgical assistants/technicians should perform tasks only under the supervision of a physician and they are allowed to perform only those steps that do not involve an incision of the body. Hence, they should not perform scoring (incision), slit making, and suturing. The assistants should be offered training on models initially, then placed as observers for the surgical process, and finally be deputed for the HT surgery. At least one of the assistants should be a paramedical staff and trained in Basic Life Support/advanced cardiac life support.

Level of Evidence: 4

Grades of Recommendation: D

TRAINING

Physicians who perform HT surgery must possess the education, training, and current competency in the field of hair restoration surgery. Membership in the national hair restoration society/global society and regular attendance at annual conferences and workshops facilitate the education and training. Fellowship courses from the International Society of Hair Restoration Surgery (ISHRS) would be an added qualification.

It is further observed that HT is not taught as a subject in any of the earlier cited courses that were listed as the eligibility criteria for an HT surgeon. Although the surgical specialties such as Mch/DNB plastic surgery, MS general surgery, and MS ENT provide an adequate surgical background, training in trichology is lacking. Likewise, MD/DNB/Diploma in Dermatology provides adequate training in trichology, but surgical training is lacking.

In view of this, this taskforce recommends that:

1. Mch/DNB plastic surgery, MS general surgery, and MS ENT doctors should undergo further training in trichology in a clinic that provides such training under a dermatologist/HT surgeon, preferably for three months, but at least for a period of 1 month.

2. Likewise, MD/DNB/Diploma in Dermatology doctors should undergo adequate training (both hands on and observational) under the supervision of an experienced HT surgeon. Although no legal guideline exists to define how much observation and supervision is needed, this taskforce recommends that at least 50 surgeries be observed and 25 surgeries be performed under supervision before starting independent practice. This training should also include training in basic surgical practices, sterilization, disinfection, and emergency resuscitation.

The taskforce is of the firm opinion that watching in workshops or on YouTube is not adequate training to start HT practice and strongly condemns and discourages such training.

Level of Evidence: 4

Grades of Recommendation: D

ETHICAL ISSUES

The use of trademarks or service marks as commercial names for a hair restoration procedure, without disclosing the scientific basis for the procedure, its complications and side effects is not in the public interest. Nor is it in the public interest to use a commercial name to market a procedure that is described under a commonly accepted name in the medical literature, without revealing the name used in the medical literature. Professional disagreements should be aired in a forum of peers. Denigration that aims at destroying another physician’s practice is morally reprehensible. Physicians who market their services have a responsibility for “truth in advertising.”

The following advertisements are considered to be misleading the public:

1. Inaccurate Credentials. Incorrectly claiming to be certified by the AHRS-I, ABHRS or claiming to be a member or Fellow of the ISHRS, and otherwise stating or suggesting any expertise in hair restoration surgery that is false.

2. Misrepresenting Board Certification. Physicians should identify their specific medical specialty certifying board when marketing their board certification in the public domain language, such as “board certified hair restoration surgeon” is not acceptable.

3. Misrepresenting Photographs. Publishing photographs of other physicians’ patients in any manner that states or suggests that they are patients of the publishing practice.

4. Copyright/Trademark Violations in General. Republishing or otherwise representing the photographs, publications, trade names, logos, or other trademarks of another practitioner without permission in violation of the owner’s copyrights and/or trademarks.

5. Misleading Language. Use of the following terms and phrases in marketing by a hair restoration surgeon may mislead the public:

“Scarless surgery”

“No incision”

“No touch”

“No cutting”

“Cloning”

“Hair multiplication”

“Non-invasive”

“Eliminates the need for additional procedures”

“Pain free or no pain”

“Unlimited grafts”

“Guaranteed results”

Level of Evidence: 4

Grades of Recommendation: D

CHARGES FOR THE SURGERY

The surgery cost should be based on the number of follicular units/follicles/package for a particular surface area as per the surgeon’s routine pricing practice. However, each term unit/graft/follicle should be explained and the patient should be familiar with the terminology. Costs should be informed beforehand to the patient and documented in the consent form.

TRANSPARENCY

Transparency in the HT surgery should be followed in the following aspects:

• The physician who will be performing the surgery and the role of assistants should be informed to the patient prior to the surgery.

• The role of the surgeon and the role of assistants should be documented – who does what

• Hairline design, once accepted by the patient and the surgeon, should be documented with an image.

• Number of grafts/ follicles/ area to be covered initially planned and actually performed should be disclosed to the patient and documented with images. The discharge slips should document the number of units of each type, 1/2/3/4 hairs total; number of units; and total number of hair separately.

• Provision of counting the grafts can be explained to the patient.

• The need for the medical management/chances of inadequate growth/ thinning of grafted follicles with time post-HT should be discussed with the patient and documented.

• Charging for the surgery should be only for viable follicles that are transplanted.

Level of Evidence: 4

Grades of Recommendation: D

DOCUMENTATION AND CONSENT

A medical record is admissible as documentary evidence in a legal suit. So it is important to maintain a meticulous record of clinical details of the patient, the counseling process, consent taking, detailed preoperative, operative, and postoperative notes and instructions, and follow-up visits.

Preoperative documentation should include the details about any preexisting health issues, drug allergy, photograph id lignocaine test dose, baseline vital parameters, hairline design planned, planned number of grafts to be harvested, expected results with duration, donor adequacy, continuation of medical management if required, and the possibility of a second surgery after a particular period.

Intraoperative records should include the vital parameters, drugs administered and their dosage, complications if any and the remedial measures that were carried out, number of grafts planted, the area of scalp covered the details of the surgical team, and the duration of the surgery with the timings of the beginning and the end of each stage of the surgery.

Immediate postoperative records should have the following details: vital parameters after the surgery, duration of observation post-surgery, complications if any at the end of the surgery, remedial measures taken, postoperative prescription and advice, emergency contact number for communication, and the details of the follow-up visit.

The patient’s failure to adhere to post-procedure consultations, neglect of precautions, and noncompliance of instructions, if any, should also find place in the record.

Both manual signed records and computerized data help in the standardization, storage, and easy retrieval of records.

Photographs taken before, during, and after the procedure provide adequate proof of the outcome of the procedure.

Medical records of HT must be preserved for five years, but those pertaining to malpractice suits must be preserved till the final settlement of the case.

The aesthetic surgeon or the hospital is vested with the custodial ownership of records. However, on request, these should be provided to the patient within 72 h.

The Consumer Protection Act can condone a delay in filing a case of negligence beyond the prescribed limitation of two years from the date of occurrence.

Consent in the medical field can be defined as an instrument of mutual communication between a doctor and a patient with an expression of authorization/ permission/ choice by the latter for the doctor to act/not act in a particular way.

Lack of informed consent is a frequent cause of allegations of medical negligence.

Consent should have the following details:

Procedure details in a language that the patient understands

Risks involved

Complications that can arise

Outcome expected

Duration of treatment (average)

Expenses involved (approximate)

Evidence Level: 3

Category of recommendation: C

COUNSELING FOR THE MEDICAL MANAGEMENT

HT surgery should not be considered as a single-step permanent solution for androgenetic alopecia (AGA), since the hair loss in AGA is a continuous process. The taskforce recommends that every patient should be educated about the importance of continuing the medical management even after the HT surgery. Topical minoxidil 2–5% and oral finasteride at a dosage of 1 mg/day are the approved medications for AGA. Dosage and duration should be individualized according to the degree of hair loss.

Level of Evidence: 1

Grades of Recommendation: A

HT PRACTICE GUIDELINES: PART 2

LIGHTING

General lighting in the theater by a fluorescent lamp-mounted flush with the ceiling is adequate.

• Fluorescent lamp: at the rate of 1 W per square foot (i.e., for 120 square feet – 120W – three tubes of 40W). Ceiling or pedestal lighting of the operation field.

• Shadowless lighting delivering 3,000–8,000 foot candles (i.e., the dental chairs have a halogen lamp of 50 W power. Each Watt of power will give 50 foot candles of illumination at the site of surgery. So 50 W of a halogen bulb can roughly give 2,500 foot candles of illumination at the site of surgery)

• It is important that heat generation by the lighting system is kept to minimum.

STERILIZATION AND DISINFECTION OF OPERATION THEATER AND INSTRUMENTS

• The operation table, chair, light, shelves, and sink should be wet mopped daily free of dust, with water and the use of a broom should be avoided. Chemical disinfectant is recommended for the floor. The wet mop used should be left in a proper place to dry.

• The OT trolley should be mopped with a chemical disinfectant or isopropyl alcohol before surgery and between two surgeries.

• The floor and other areas of blood spillage should be mopped with a chemical disinfectant. The operating room wall and ceiling need to be cleaned periodically.

• The use of a fan in the OT should be avoided, as it causes aerosolization of dust.

• Regular maintenance of the air conditioner is necessary. The tonnage of air conditioner depends on the size of the room to ensure adequate cooling.

• After an HT surgery, the instruments should be rinsed in 0.5% chlorine for 10 min and then should be washed in water and scrubbed with a brush before sending them for sterilization.

• Linen, draped, gowns: Should be washed with a detergent at 71degrees for 25 min, and then sent for sterilization.

FUMIGATION

Formaldehyde fumigation can be done initially during a start-up of the theater or after an overhaul cleaning process. Formaldehyde 6%, glutaraldehyde 6%, and benzalkonium chloride 5% can be used by adequate trained personnel wearing appropriate protective devices. A combination of stabilized hydrogen peroxide 11% w/v and diluted silver nitrate solution 0.01% w/v is an ideal aerial disinfectant and OT fumigant acting as a sterilant at a recommended concentration of 20% at 1 h contact time. Fumigation should be done daily or prior to each surgery.

In between two operative procedures on the same day, spot cleaning of operation tables, theater equipment with disinfectant solution is recommended. In case of spillage of blood/body fluids, decontamination with bleaching powder/chlorine solution should be done. Fumigation should be repeated prior to the second surgery, if performed on the same day.

AUTOCLAVE

• All material should be dried and wrapped in cloth or medical grade paper.

• The instruments should be laid so that all surfaces come in contact with heat.

• Time depends on individual recommendations, but it is usually 121degrees for 15 min.

Chemical sterilization of instruments:

• Cleaned, disinfected, and dried instruments should be fully soaked in a steel or plastic container having 2% glutaraldehyde for 8–10 h.

• After 10 h, using autoclaved water (100 mL of water autoclaved for 20 min and not boiled water) the instruments should be washed, dried, packed, and stored in a sterile tray. Note that the contact time for high-level disinfection is just 20 min compared with the 10 h required for sterilization.

Sterilization of follicular unit excision machines and implanters:

Heat- and moisture-sensitive electronic goods and other implanters are sterilized using ethylene oxide sterilization.

Grade of recommendation: C

Level of Evidence: 3

BIOMEDICAL WASTE MANAGEMENT

• Segregation, collection, transportation, storage, and disposal of biomedical waste should be as per biomedical waste handling rules, and that of general waste should be as per applicable local laws.

Grade of recommendation: D

Level of Evidence: 4

PREOPERATIVE CONSIDERATIONS

A detailed preoperative evaluation of the patient’s medical status is essential. It is recommended to get the patient assessed opined upon by a treating doctor or an independent physician regarding the patient’s eligibility to undergo HT.

CASE SELECTION WITH ReSPECT TO AGE

Age is an important, but not the only consideration for case selection. Since AGA is a continuous and progressive condition, early surgery would lead to future hairloss negating the results of surgery and causing an ugly recession that can affect the patient psychologically. Further, younger individuals cannot be relied upon to adhere to long-term drug therapy. Younger individuals are also likely to have unrealistic expectations and often expect a cure of AGA by HT. For these reasons, HT in the early age group is not recommended and it is preferable to wait till at least 23–25 years of age. It is also preferable to treat such patients with medical management for a few months, develop rapport, and then decide for surgery.

However, there are some special situations where early surgery may be necessary in patients who are between 21 and 23 years of age:

1. Advanced hair loss Hamilton–Norwood stages 4–6, which causes severe psychological issues and where drug therapy is unlikely to be beneficial.

2. Young patients in special professions such as acting, media, modeling, etc, whose career gets affected by postponing surgery.

3. Patients who are severely psychologically affected by their baldness.

4. In cases of tractional alopecia, secondary cicatricial alopecias (burns, trauma, surgical scars over hair-bearing regions).

In all these cases, extensive counseling over several sessions, preferably in the presence of their parents, is advocated. This taskforce does not recommend surgery in those younger than 21 years of age.

Level of Evidence: 4

Grades of Recommendation: D

PREOPERATIVE INSTRUCTIONS

The expert committee recommends the following instructions before the HT surgery: Allergies to any medications in the past, history of previous surgeries, complications if any, and the medications currently being consumed by the patient should be documented in the case sheet. Medications for hypertension, epilepsy, thyroid, and diabetes should be continued, if any, as per the treating physician’s recommendation and medical clearance from the physician is recommended for those with history of any cardiac surgeries or cardiac procedures. Specific instructions as per the operating surgeon need to be followed.

Preoperative check list:

1. Minoxidil to be stopped one week prior to the procedure, as it may increase bleeding.

2. Alcohol to be avoided seven days before and after the procedure.

3. Smoking should be reduced as much as possible before the surgery and it would be safe to stop it entirely.

4. Preoperative tranquilizer in an anxious patient.

5. NSAIDS to be restricted 12–24 h before the surgery.

6. Antihypertensives to be continued on the day of the surgery. Beta-blockers to be avoided on the day of the surgery.

7. Vitamin supplements and herbal preparations to be avoided for three weeks before the surgery.

8. Lignocaine test dose for sensitivity, preferably one day prior to the surgery to account for delayed allergic reaction to the local anesthetics.

9. Preoperative photographs: standard positions.

Front facial, chin to chest, right oblique, left oblique, and vertex view

Level of Evidence: 4

Grades of Recommendation: D

PREOPERATIVE LABORATORY WORKUP

Preoperative laboratory studies to be performed in all age groups include Hb%, blood counts including platelet count, bleeding and clotting time (or prothrombin time and activated partial thromboplastin time), venereal disease research laboratory, ECG, fasting blood sugar, antibodies for hepatitis B and C surface antigen, and HIV screening tests.

INVESTIGATIONS IN SPECIAL SITUATIONS

Electrocardiography

Routine electrocardiography is not recommended routinely before HT surgery; however, it is advisable to perform it in the following circumstances:

In a patient with any present or past cardiac symptom (including breathlessness, pre-syncope, syncope, or chest pain) or history of cardiac disease or obesity or metabolic syndrome.

Patients with abnormal ECG are recommended to get a cardiologist’s opinion before the surgery.

PREOPERATIVE EVALUATION IN HYPERTENSIVES

In patients with hypertension undergoing surgery, it is recommended to continue most antihypertensive medications until surgery, including the morning of the surgery. Medical fitness for HT surgery should be obtained from the physician. Intraoperative management of hypertension should be done in association with the anesthetist.

EVALUATION IN DIABETICS

A preoperative assessment should be done with support from a diabetologist/endocrinologist. It should occur sufficiently in advance of the planned surgery to ensure optimization of glycemic control as per the recommendation of the treating physician for the particular patient, before the date of the proposed surgery. People with diabetes should have their most recent HbA1c test results analyzed. HbA1c testing should be offered to people with diabetes having surgery if they have not been tested in the past three months. With appropriate guidance, patients with diabetes should be allowed to retain control and possession of, and continue to self-administer, their medication. The aim is to avoid hypoglycemia or hyperglycemia during the period of fasting and the time during and after the procedure, until the patient is eating and drinking normally.

Routine HbA1c testing before surgery to people without diagnosed diabetes is not essential.

Level of Evidence: 4

Grades of Recommendation: D

PRE-OP DRUG THERAPY BLOOD THINNERS

HT surgery is a cosmetic surgery and those patients who are on blood thinners and undergoing HT surgery might have the following issues:

1. Issues in donor area: Increased bleeding during and after surgery.

2. Issues in recipient area: Bleeding during implantation and postoperatively leading to poping, displacement, and poor results affecting the outcome.

These patients also may have underlying cardiac conditions that may necessitate avoidance of adrenaline. This will be an additional challenge as it increases bleeding and also leads to shorter action of lignocaine, needing additional doses of lignocaine, with the possibility of cardiac side effects by lignocaine overdosage. Bupivacaine also needs careful consideration in such patients because of its cardiac effects.

However, blood thinners are lifesaving and hence cannot be stopped casually, that too for a cosmetic surgery. Any decision to perform surgery in such patients, therefore, needs a careful assessment of risk versus benefit and is subject to clearance by a cardiologist/physician. Management of the antiplatelets and anticoagulants should be carried out as per the advice of the concerned physician. The presence of an anesthetist is mandatory during the procedure in such patients.

Level of Evidence: 4

Grades of Recommendation: D

PREMEDICATION

The primary aim of premedication is to relieve the patient’s anxiety/restlessness before anesthesia and to ensure optimum quantity and quality of sleep on the night preceding surgery. With these objectives in mind, oral benzodiazepines are the preferred choice. The taskforce recommends the use of Alprazolam at a dose of 0.5 mg.

Level of evidence: 3

Category of recommendation: C

ANTIMICROBIAL PROPHYLAXIS

HT is categorized as a clean procedure; the taskforce recommends the administration of antimicrobial prophylaxis with cephalosporins since cephalosporins 1 h preoperative administration is the most commonly used antibiotic for prophylaxis, apart from Cephadroxil 500 mg one tablet during the night before the surgery, one tablet on the morning of the surgery (before the surgery), and one tablet during the night after the surgery. A full course of five days of antibiotics should be administered in cases of surgery over the facial region. If the patient gives a history of sensitivity to penicillin, then an antibiotic from the macrolide group or Clindamycin can be used. Optimum serum and tissue levels must be reached prior to incision and maintained throughout the procedure and only for a few hours post-op.

Level of evidence: 3

Category of recommendation: C

ANTISEPTIC PROPHYLAXIS

Proper cleansing of the surgical areas (scalp, beard, torso, etc.) before surgery helps in reducing colony counts of the local bacteria. It is recommended to advise the patients to shower or bathe (full body) with soap (antimicrobial or non-antimicrobial) or an antiseptic agent plus shampoo (Povidone iodine + Shampoo) on the night before and on the morning of the operative day.

Level of evidence: 4

Category of recommendation: D

HT PRACTICE GUIDELINES: PART 3

TECHNIQUES TO REDUCE PAIN OF ANESTHESIA INJECTION

Most of the pain associated with a HT is during the local anesthesia (LA) injection. There are many techniques to reduce the perception of this pain. They could be used singly or in combination:

• a.

  Topical anesthesia: Eutectic mixtures help in reducing the initial pricking pain felt on piercing the skin with a needle. These mixtures need to be applied at least an hour before the injection of the anesthetic. Common mixtures used contain lignocaine with tetracaine or prilocaine.

• b.

  Warming the local anesthetic solution.

The simple procedure of warming to 37°C reduced the pain associated with a subcutaneous injection of lignocaine.

• c.

  Buffering the LA solution (Carbonation and pH adjustments).

The addition of sodium bicarbonate to the LA in order to raise the pH (known as buffering) decreases patient pain during drug delivery via subcutaneous or intradermal infiltration.

Most solutions were prepared by mixing 8.4% sodium bicarbonate and 1% lidocaine with epinephrine in a 1:9 or 1:10 ratio by volume; both proportions are effective in practice.

• d.

  Slow rate of injection.

Reducing the rate of administration of LA reduces pain and may have a greater impact on pain than buffering.

• e.

  Simultaneous stimulation of the surrounding skin

Based on the gate control theory, concomitant physical stimulation (non-painful input) closes the “gates” to painful input, which prevents pain sensation from traveling to the central nervous system. Stimulation of the skin using a vibrating device in the same dermatome results reduced perception of painful stimuli.

Level of evidence: 2

Category of recommendation: B

LOCAL ANESTHETICS

The common anesthetics used for local anesthesia (LA) in HT are Lignocaine (with or without adrenaline), Bupivacaine, Levobupivacaine, and Ropivacaine.

Lignocaine is the most common LA used in HT surgery. The generally recommended maximum dose (Total Daily Dose) for local infiltration is 300 mg or 4.5 mg/kg of body weight. This can be increased to 500 mg or 7 mg/kg after adding adrenaline.

However, it is well recognized that the routine recommendations for infiltration anesthesia are not fully relevant in HT for the following reasons:

1. Tumsecent anesthesia is practiced in HT and tumescent anesthesia allows higher doses to be administered.

2. Since multiple holes are made in the skin, in both donor and recipient area, much of the anesthetic oozes out and is not absorbed.

3. Anesthesia is administered in a graded fashion several times during the long surgery, and, hence, peak values may not be achieved.

However, it is advised that a careful watch is maintained on the amount of anesthetics administered, the quantity given be recorded and documented, and every effort made not to administer excess of anesthetic.

BUPIVACAINE

Bupivacaine is the most commonly used long-acting LA for HT surgery. The maximum daily dose is 175 mg. The use of bupivacaine is limited because of its potential cardiac toxicity. Bupivacaine produces a significantly greater depression of LV pressure than ropivacaine, mepivacaine, or lidocaine. Though these effects are rare with safe dosages, nevertheless there is potential for catastrophic events to occur.

LEVOBUPIVACAINE

Levobupivacaine is the pure S (−) enantiomer of bupivacaine and has emerged as a safer alternative for regional anesthesia than its racemic parent Bupivacaine. The maximum dose for levobupivacaine is 2 mg/kg and the maximum one-time dose is 200 mg. It is a viable alternative to bupivacaine as it is less cardiotoxic but the duration of action is less than bupivacaine but more than ropivacaine and ligocaine. Most of the clinical studies suggest that levobupivacaine is relatively less potent than bupivacaine, but it is more potent than ropivacaine.

ROPIVACAINE

Ropivacaine is a long-acting, enantiomerically pure (S-enantiomer) amide LA and regional anesthetic with an efficacy that is broadly similar to that of bupivacaine. In concentrations of 0.5% and higher, it produces dense blockade with a slightly shorter duration than that of bupivacaine. Various clinical trials have evaluated the safety profile of ropivacaine and found it to be safe. The maximum dose is 3 mg/kg and the maximum one-time dose is 200 mg.

MIXING LOCAL ANESTHETICS

It is unclear whether mixing multiple anesthetics for local infiltration poses further beneficial overuse of a single agent. The systemic effects produced by combinations of LA follow the principles of summation. When adhering to dosage limits, guidelines for various agents should be regarded as additive.

COMBINING LOCAL ANESTHETICS AND ADRENALINE

Use of the lowest effective concentration of adrenaline to provide pain control and vasoconstriction in local infiltrative anesthesia is recommended. The safe dosage of adrenaline is 0.01 mg/kg body weight. It is contraindicated in patients using the nonselective beta-blockers such as propranolol, since concomitant LA administration results in unopposed alpha-receptor mediated vasoconstriction, which can theoretically produce a hypertensive emergency and a profound vagally mediated reflexive bradycardia. Local infiltrative anesthesia with adrenaline may be administered to patients with stable cardiac disease.

Category of recommendation: C

Level of evidence: 3

SYSTEMIC TOXICITY OF LOCAL ANESTHETICS

Local anesthetic systemic toxicity (LAST) is a life-threatening adverse event that may occur after the administration of local anesthesia (LA) drugs through a variety of routes. In event of the overdose of LA toxicity, immediate management involves the general safety and resuscitation measures that are essential in any emergency. The taskforce recommends the following actions in case of LAST: The LA injection should be stopped; immediate priority is to manage the airway, breathing, and circulation; and the transfer of the patient to a tertiary care hospital should be planned. Early administration of 20% intravenous lipid emulsion therapy is recommended. An initial bolus of 100 mL should be administered over 2–3 min (1.5 mL/kg if the lean body weight is <70kg). This is then to be followed by a 20% lipid emulsion infusion of 200–250 mL over 15–20 min (0.25 mL/kg/min if the lean body weight is <70kg). If circulatory stability is not attained, re-bolusing up to two further times or increasing the infusion to 0.5 mL/kg/min is suggested. The maximum recommended dose of 20% lipid emulsion is 12 mL/kg.

Seizure activity may exacerbate metabolic acidosis, and prompt prevention and termination is crucial. Due to their cardiostable profile, benzodiazepines are the first-line therapy.

Advanced Cardiac Life Support algorithms for cardiopulmonary resuscitation must be followed should cardiac arrest occur. Chest compressions should be initiated immediately and continued until return of spontaneous circulation. If epinephrine is used, small initial doses of ≤1 µg/kg are preferred to avoid impaired pulmonary gas exchange and increased afterload.

Level of evidence: 3

Category of recommendation: C

EMERGENCY PREPAREDNESS IN HAIR TRANSPLANTATION

Plastic surgeries are classified into three types by the American Association for Accreditation of Ambulatory Surgery Facilities: Class A, minor plastic surgery procedures performed under local, regional, or topical anesthesia; Class A/B, minor or major plastic surgeries performed under intravenous or parenteral sedation, analgesia, or dissociative drugs; and Class A/B/C, major plastic surgeries performed under general anesthesia requiring external support of vital body functions. Surgeries are classified into three types based on the levels of Surgical Complexity: Level 1

• Minimal risk to the patient independent of anesthesia

• Minimally invasive procedures with little or no blood loss

• Often done in an office setting with the operating room principally for anesthesia and monitoring. HT surgery is categorized as Level I surgery and the facility it is performed in is Class A.

Monitoring the following equipment is mandatory for an HT OT:

1. Non-mercury/digital blood pressure apparatus

2. Stethoscope

3. Pulse oximeter

4. Glucometer

5. Digital thermometer

6. Weighing scale

RESUSCITATIVE EQUIPMENT NECESSARY FOR HAIR TRANSPLANT OPERATION THEATER

Resuscitation equipment should be located either in the room or within the premises, to allow basic cardiopulmonary resuscitation. Although there is some medico-legal responsibility, the major concern should be patient safety.

1. Intravenous access cannulas and IV sets

2. Laryngoscope

3. Endotracheal tubes

4. Suction equipment

5. Xylocaine spray

6. Airways: oropharyngeal and nasopharyngeal

7. Ambu Bag: Adult

8. Oxygen cylinders with flow meter/ tubing/catheter/face mask/nasal prongs

9. Defibrillator with accessories (AED preferable)

10. Equipment for dressing/bandaging/suturing

11. ECG Machine

EMERGENCY DRUGS NECESSARY FOR HAIR TRANSPLANT OPERATION THEATER

1. Inj Adrenaline 1 mg

2. Inj Hydrocortisone 100 mg

3. Inj Atropine 1 mL

4. Inj. Pheniramine maleate 10 mL

5. Inj. Promethazine 1 mL

6. Inj. Deryphyline 2 mL

7. Inj. Frusemide 4 mL

8. Inj. Metoclopramide 2 mL

9. Inj. Dexamethasone 2 mL

10. Inj. Diazepam 10 mL

11. Inj. Dicyclomine Hydrochloride 2 mL

12. Inj. Ligocaine without preservative 30 mL

13. Inj. Intralipid 20% 500 mL

14. Inj. 5% dextrose infusion 100 mL

15. Inj. Normal saline 500 mL

Regular inspection of the drugs just mentioned to check their expiry dates should be done periodically.

LIFE SUPPORT TRAINING

Though rare, an HT surgeon may encounter an unresponsive patient or a sudden collapse in a patient. Preventing hypoxic brain damage is the most important task for the surgeon. The surgeon should have been trained in emergency resuscitation skills. If not, an anesthetist should be available for care in such situations. In addition, at least another member of the HT team should be trained in Basic Life Support.

Level of evidence: 4

Category of recommendation: D

TRANSFER ARRANGEMENTS

An arrangement should exist with a nearby hospital for the transfer of patients in the event of unexpected serious or potentially serious developments. Surgeons performing office-based HT surgery must have admitting privileges at a nearby hospital or maintain an emergency transfer agreement with a nearby hospital. Ambulance or patient transport services, if provided, should be organized through defined policies and procedures for efficient and effective services. Ambulance or patient transport services, if provided, should comply with the legal and regulatory requirements. Relevant telephone numbers should be displayed prominently, and all staff should be familiar with the telephone numbers.

PRESENCE OF ANESTHETIST DURING HAIR TRANSPLANT PROCEDURE

Typically, patients of HT belong to ASA 1 category (normal healthy patient, nonsmoking, no or minimal alcohol use) and hence the presence of an anesthetist is not routinely necessary. The presence of an anesthetist is not necessary if:

• (a)

  the surgeon is well versed with advanced cardiac life support skills

• (b)

  the team is Basic Life Support certified

• (c)

  all the necessary monitoring and resuscitative equipment is handy

• (d)

  anesthetist services can be accessed easily and quickly

• (e)

  the anesthetist services have transfer arrangements with a nearby hospital

When dealing with ASA II (patient with mild systemic disease without substantive functional limitations): Examples include (but not limited to): current smoker, social alcohol drinker, obesity (30 < BMI <40), well-controlled diabetes mellitus/hypertension, mild lung disease, elderly patient, etc. In such cases, the presence of an anesthetist is advised by the taskforce. Some hair restoration surgeons use parenteral sedatives to create a state of conscious sedation during local anesthesia administration. In this scenario also, the taskforce recommends that the presence of a qualified anesthetist is necessary, not only to monitor the patient but also to manage the patient in case the level of sedation becomes deeper.

The taskforce recommends routine periodic recording and documentation of the vital parameters during the course of surgery. It would be optional for ASA grade 1 but mandatory for ASA grade 2 (hypertension, mild cardiac disease, etc.).

Level of evidence: 4

Category of recommendation: D

HT PRACTICE GUIDELINE: PART 4

MINIATURIZATION IN THE DONOR AREA

A safe donor area should be evaluated for miniaturization and if present, this should be informed to the patient; excision of grafts should be done carefully to avoid miniaturized hairs since this might hamper the HT result and overharvesting might leave visible depletion of the donor zone. Diffuse type of AGA should always be considered in such cases. Medical treatment and body hair harvesting should be considered in these types of patients.

Grade of Recommendation: D

Level of evidence: 3

MAXIMUM GRAFTS THAT CAN BE SAFELY HARVESTED FROM SDA

This would depend on:

• a)

  Safe donor area

• b)

  Donor density of both hairs and units

• c)

  Size of head

• d)

  Techniques used

• e)

  Donor skin properties such as elasticity

• f)

  Age of patient and possibility of future sessions

Hence, individual variations may occur. The range of safe upper limit can vary from 4000 to 6500 scalp grafts over a lifetime over multiple sessions and different techniques. Without causing visible depletion of the donor area in one session, an average of 2500 to 3000 grafts per session is considered as the optimum upper limit of graft harvesting.

Grade of Recommendation: D

Level of evidence: 3

FOLLICULAR UNIT EXCISION

Follicular unit excision (FUE) involves harvesting hairs from the donor area, under local anesthesia, which is most commonly the scalp but occasionally the beard, chest, and other parts of the body, using circular punches of less than 1 mm diameter, mounted on a manual handle or a motorized hand device or, more recently, a robotic device. There are several options for the punches available. The taskforce recommends that the choice of the punch depends on the individual surgeon’s comfort level in reducing the transection of the follicles and to provide optimum outcome and the diameter of the punch to be preferably less than 1 mm. Punches larger than 1 mm are not recommended. Patients’ skin characteristics such as variations in the thickness of epidermis, dermal–epidermal junction, and subcutaneous tissue contribute to the challenges of donor harvesting and for obtaining low follicular transection rates. Overharvesting should be avoided, as it may lead to scarring and depigmentation, particularly in patients with darker skin. It is preferable to excise 1 unit out of four follicular units, leaving one intact all around. A general recommendation is to harvest 10–15 excisions/cm² as a safe single-pass density in a person with a baseline average density of 65–75 follicles/cm². A good magnification device is recommended for the FUE procedure to orient for the follicular unit angle of exit and better excision without transaction.

Level of evidence: 3

Category of recommendation: C

STRIP EXCISION

The size of the strip depends on the demand of number of grafts at recipient site, donor zone elasticity and the donor hair density. Preoperative estimation of scalp laxity and glidability will aid in determining the optimal width to be harvested and also in preventing wound dehiscence postoperatively. The width of the scar is directly proportionate to the width of the strip removed and tension on the wound margins. The width should be preferably less than 1.3 cm. It may be necessary to alter the width of the strip in some areas of increased tension or due to the presence of a preexisting scar.

Evidence level: 3

Grade of recommendation: C

STRIP HARVEST

A single-strip elliptical excision is the gold standard technique with a strip centered around occipital protuberance. More superficial scoring incision, angle of the blade parallel to the hair shaft, blunt dissection for separating the scored tissue, and working under good magnification result in lesser transaction rates during the strip excision. It is advisable to wait for a minimum of 9–12 months before taking a revision strip surgery.

WOUND CLOSURE

Depth of dissection and undermining of the edges has been the subject of much debate and at present no uniform recommendations can be made. However, deeper dissection and undermining is associated with a greater risk of injury to vessels and therefore bleeding, needing greater surgical skills. Excessive inadvertent coagulation should be avoided, as it can damage the surrounding follicle and eventually delay healing and might lead to a bad scar.

SUTURING AND SUTURE MATERIAL

• Closure of the strip wound may be performed with sutures (either continuous or intermittent) or with staples, as each of these has its own advantages. The running suture can strangulate the follicles if wound tension is more or if there is significant post-op edema, and it can result in localized hair loss around the suture line and a bad scar unlike staples.

• The quality of the scar is dependent on the amount of width of the strip that is removed during the surgery. Though single-layer closure has been reported to be much faster and cost-effective than double-layer closure, taskforce recommends that strips less than 1.2 cm can be closed in a single layer and that strips more than 1.2 cm must be closed in a double layer.

• Trichophytic closure results in minimizing scarring by regrowing hair through the scar tissue and hence camouflages donor scars. Deepithelialization of the inferior edge of the scalp wound margin is recommended, as the upper edge will slide over the deepithelialized lower edge during the wound closure during the trichophytic closure technique.

• To minimize the reaction from the absorbable sutures, it has been suggested that the use of nonabsorbable sutures such as 3 “0” Nylon interrupted sutures, for the deeper layer to reduce tension on the suture line. The skin can be approximated with 4”0” polyglactin910.

Evidence level: 3

Grade of recommendation: C

MAGNIFICATION FOR THE WORKING FIELD

Magnification for the working field and a clear visualization of the follicles is essential to avoid transection during the process of strip harvesting, slivering, and dissection of follicular units. Various magnification devices such as a stereo microscopes, video microscopes, and magnifying loupes have been routinely used by the surgeons and their team. It is recommended that stereomicroscopic dissection be done for proper identification and dissection to minimize transaction during the slivering process. Though stereomicroscopic dissection at magnification of 10–25x gives a good clarity, magnification of 2.5 to 4x can be used to dissect the slivers into follicular grafts.

Evidence level: 3

Grade of recommendation: D

RECIPIENT AREA

Female hair transplant and planning and designing anterior hairline

Detailed counseling is necessary in women who have an unrealistic expectation of achieving a full head of hair after the HT. Even when surgical technique and hair survival is excellent, the patient may be very dissatisfied because of poor communication and/or mismatched expectations.

A detailed examination of the recipient area and the donor area to look for diffuse thinning is necessary. General physical examination to look for underlying medical conditions, nutritional deficiencies, and other systemic diseases should be done in all the female patients. These women need to be counseled to seek alternative treatments, including medical treatments, scalp-coloring agents, improved hairstyling, or hairpieces.

Commonly, the areas treated in women include one or more of the following: the hairline, the midline frontal zone just posterior to the hairline, a desired part-line, the center of the vertex, the frontotemporal recessions, and the central caudal region.

Planning of anterior hairline in females

1. Hairline is at a lower level on the vertical portion of the forehead.

2. Frontotemporal angle is obtuse and rounded.

3. A widow’s peak or cowlick is usually located in the center of the AHL; the central peak is generally associated with later smaller peaks or mounds.

Level of evidence: 4

Category of recommendation: D

SOME IMPORTANT SPECIFIC ISSUES

COMBINATION SURGERIES

In several situations, a combination of techniques (FUT and follicular unit excision) or harvesting from multiple areas (scalp, beard, body) may be needed. These include: advanced grades of alopecia, to maximize the output of the donor grafts, during revision surgeries, second session, diffuse pattern hair loss, and in those with limited donor area combination. Such combination surgeries require expertise in view of longer operating hours, increased anesthetic dose, and patient tolerance. Such combinations can be done either on the same day, after proper assessment by the treating surgeon, or on separate days, depending on the given situation in each case.

Grade of Recommendation: D

Level of Evidence: 3

PRP IN ANDROGENETIC ALOPECIA AND HT

The available literature suggests that PRP may be effective in treating AGA and may act to reduce hair loss, increase hair diameter and density. However, there exist large variations in optimal PRP preparation method, the optimal frequency, treatment interval, and the long-term efficacy of PRP treatment.

To validate the efficacy and safety of PRP in treating hair loss, more RCTs are required, with standard protocols concerning more objective evaluation of hair loss, the number and interval of treatment sessions, the number of platelets, the method of activation, and the long-term follow-up outcomes.

It is also true that an increasing number of publications have been produced over the past two years, though of lower quality, and the treatment is easy, safe, and cheap. Hence, the taskforce recommends its use as an adjuvant along with other modifications and not as a monotherapy or first-line treatment. The recommendation can be renewed as further evidence becomes available.

The PRP is also used in various steps of the HT procedure intraoperatively to augment the result of HT. The studies reported so far, though small, have documented the reduction in postoperative hair loss after HT and early regrowth of implanted hair. PRP treatment is safe during HT and has strong logic, but it needs validation through proper controlled trials. It is also true that there is no other ideal holding solution. Taskforce recommends its use during the procedure with proper informed consent.

Level of evidence: 2

Category of Recommendation: B

SUMMARY

The objective of these guidelines is to recommend minimum standards for practice of HT. The principles outlined in these guidelines are of a general nature only and are not meant to cover all situations. The taskforce emphasizes that each patient has to be treated on his/her own merit and that these guidelines do not limit the physician from making an appropriate choice or the necessary innovation for a given patient.