Role of Bandage After FUE Hair Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of this interventional study is to determine the role of bandage on the follicular donor sites on the scalp after FUE hair transplantation. A randomized side of the scalp will be covered using bandage, the other side will be left naked. Subjects under study will be evaluated after the procedure is completed, and day 1 and day 7 post-procedure during the healing phase. This will in turn help, answering the importance of bandage in healing of the donor site post-hair transplantation.

Detailed Description
-----------------
In this modern era, hair-transplantation has become very common. Interests in wound healing is not new; with every passing day, different techniques are introduced to get better results for the patients. The current literature available online shows that many hair-transplant centers have stated about using bandage on the donor area post-transplantation, however, there isn't a single study available to augment this use of bandage. On the other hand, data regarding application of antibiotic ointments and silicon gels is available. The punctures made during FUE are only of 9-10mm, requiring no sutures. In addition to this, the blood supply of the scalp also favors quick healing. The process of re-epithelization starts within a few hours of injury and progresses over the first 1 to 3 days. Most of the clinics remove, the bandage after 24hrs, disrupting the healing process of the skin. In the present study, the investigators sought to compare bandage versus no-Bandage donor site in terms of healing. The investigators hypothesize that, compared with bandage site, no-bandage donor site after FUE will have reduce post-procedural downtime and donor site inflammation ultimately, enhancing patient satisfaction with the procedure. The long-term goal of this study is to get evidence-based usage of bandage, if results are in contrast with the hypothesis.

Official Title
-----------------
Bandage Versus No-Bandage After Follicular Unit Extraction Hair Transplantation

Conditions
-----------------
Hair Loss/Baldness

Intervention / Treatment
-----------------
* Device: Bandage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Able to provide informed consent Planning to undergo follicular unit extraction hair restoration Exclusion Criteria: Significant medical or surgical conditions Unable to give informed consent Immunocompromised

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a single center, triple-blind, within subject split scalp study investigating the comparison of bandage versus no bandage donor site post FUE. Twenty-five subjects desiring to undergo FUE for hair restoration will have bandage on one half of the donor area on the back of the scalp and no-bandage on the other side for 24 hours post procedure. The sides of the scalp will be randomized, and the evaluating physician will be blinded. Subjects will be evaluated, photographed, and will fill out subject reported questionnaires live at days 1 (+1) and 7 (±1) post procedure.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Treatment left<br>A randomized side of the scalp will be covered with bandage, the other side with no bandage. Intervention: Device: Treatment - Bandage | Device: Bandage<br>* To determine if using bandage versus no-bandage, plays a role in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure<br>* Other names: wound healing;|
| Experimental: Experimental: Treatment right<br>A randomized side of the scalp will be covered with bandage, the other side with no bandage. Intervention: Device: Treatment - Bandage | Device: Bandage<br>* To determine if using bandage versus no-bandage, plays a role in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure<br>* Other names: wound healing;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1) | Bandage has protection role to some extent; however, removal of bandage will affect the normal healing of donor site. Healing Response (4-point ordinal scale) LEFT SIDE Not healed at all (0%) Mildly healed (33%) Moderately healed (66%) Completely healed (100%) RIGHT SIDE Not healed at all (0%) Mild healing (33%) Moderately healed (66%) Completely healed (100%) | duration of the study be evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the bandage and no bandage sites | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hair Loss, Follicular Unit Extraction, Hair transplantation, Wound healing