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Role of Bandage After FUE Hair Transplantation

Primary Purpose

Hair Loss/Baldness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bandage
Sponsored by
Pak Medical and Diagnostic Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hair Loss/Baldness focused on measuring Hair Loss, Follicular Unit Extraction, Hair transplantation, Wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Experimental: Treatment left

    Experimental: Treatment right

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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%)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 2, 2023
    Sponsor
    Pak Medical and Diagnostic Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05984862
    Brief Title
    Role of Bandage After FUE Hair Transplantation
    Official Title
    Bandage Versus No-Bandage After Follicular Unit Extraction Hair Transplantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pak Medical and Diagnostic Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hair Loss/Baldness
    Keywords
    Hair Loss, Follicular Unit Extraction, Hair transplantation, Wound healing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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
    Care ProviderInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: Treatment left
    Arm Type
    Experimental
    Arm Description
    A randomized side of the scalp will be covered with bandage, the other side with no bandage. Intervention: Device: Treatment - Bandage
    Arm Title
    Experimental: Treatment right
    Arm Type
    Experimental
    Arm Description
    A randomized side of the scalp will be covered with bandage, the other side with no bandage. Intervention: Device: Treatment - Bandage
    Intervention Type
    Device
    Intervention Name(s)
    Bandage
    Other Intervention Name(s)
    wound healing
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)
    Description
    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%)
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jawad Jahangir, MBBS, FCPS,ABHRS
    Phone
    +923205636745
    Email
    j.jabbasi@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muhammad Sarfraz Khan, BSc, MBBS
    Organizational Affiliation
    Pak Medical and Diagnostic Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Role of Bandage After FUE Hair Transplantation

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