Role of Bandage After FUE Hair Transplantation

Not Applicable

Not yet recruiting

• Conditions: Hair Loss/Baldness
• Interventions: Device: Bandage

• Registration Number: NCT05984862
• Lead Sponsor: Pak Medical and Diagnostic Center

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.

Study Timeline

• Study First Submitted: 2023-07-25
• Status Verified: 2023-08
• Study Start: 2023-08-01
• Study First Submitted QC: 2023-08-02
• Last Update Submitted: 2023-08-02
• Study First Posted: 2023-08-09
• Last Update Posted: 2023-08-09
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: Treatment left	Bandage	A randomized side of the scalp will be covered with bandage, the other side with no bandage. Intervention: Device: Treatment - Bandage
Experimental: Treatment right	Bandage	A randomized side of the scalp will be covered with bandage, the other side with no bandage. Intervention: Device: Treatment - Bandage

Primary Outcome Measures

Name	Time	Method
Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)	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	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%)