Clinical trial NCT05984862: Role of Bandage After FUE Hair Transplantation
Official title: Bandage Versus No-Bandage After Follicular Unit Extraction Hair Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hair Loss/Baldness
Keywords: Hair Loss
Follicular Unit Extraction
Hair transplantation
Wound healing
Lead sponsor: Pak Medical and Diagnostic Center
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pak Medical and Diagnostic Center
name: Muhammad Sarfraz Khan, BSc, MBBS
role: STUDY_DIRECTOR
References: