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Role of Bandage After FUE Hair Transplantation

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ClinicalTrials.gov Identifier: NCT05984862
Recruitment Status : Not yet recruiting
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Muhammad Sarfraz Khan, Pak Medical and Diagnostic Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hair Loss/Baldness Device: Bandage Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Bandage Versus No-Bandage After Follicular Unit Extraction Hair Transplantation
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Treatment left

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

Intervention: Device: Treatment - Bandage

 Device: 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
Other Name: wound healing
Experimental: Experimental: Treatment right

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

Intervention: Device: Treatment - Bandage

 Device: 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
Other Name: wound healing


Outcome Measures
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Primary Outcome Measures :
  1. Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1) [ Time Frame: 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%)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984862


Contacts
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Contact: Jawad Jahangir, MBBS, FCPS,ABHRS +923205636745 j.jabbasi@hotmail.com

Sponsors and Collaborators
Pak Medical and Diagnostic Center
Investigators
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Study Director: Muhammad Sarfraz Khan, BSc, MBBS Pak Medical and Diagnostic Center
More Information
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Responsible Party: Muhammad Sarfraz Khan, Research Associate, Pak Medical and Diagnostic Center
ClinicalTrials.gov Identifier: NCT05984862    
Other Study ID Numbers: PMDC-23-07-6745
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muhammad Sarfraz Khan, Pak Medical and Diagnostic Center:
Hair Loss
Follicular Unit Extraction
Hair transplantation
Wound healing
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical