Role of Bandage After FUE Hair Transplantation

NCT ID: NCT05984862

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hair Loss/Baldness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
This is a randomized, triple-blind, split-scalp study. The subjects will know what side of the scalp the bandage products are applied. However, during evaluation, the subjects and analyst will be shown close-up pictures of the two sides without exposing the patient's identity and actual sides.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: Treatment left

A randomized side of the scalp will be covered with bandage, the other side with no bandage.

Intervention: Device: Treatment - Bandage

Group Type EXPERIMENTAL

Bandage

Intervention Type DEVICE

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

Experimental: Treatment right

A randomized side of the scalp will be covered with bandage, the other side with no bandage.

Intervention: Device: Treatment - Bandage

Group Type EXPERIMENTAL

Bandage

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bandage

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

wound healing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pak Medical and Diagnostic Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Muhammad Sarfraz Khan

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muhammad Sarfraz Khan, BSc, MBBS

Role: STUDY_DIRECTOR

Pak Medical and Diagnostic Center

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jawad Jahangir, MBBS, FCPS,ABHRS

Role: CONTACT

+923205636745

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PMDC-23-07-6745

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.