Role of Bandage After FUE Hair Transplantation

NCT05984862 | Unknown

• 1 other identifier: PMDC-23-07-6745
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hair Loss/Baldness

Keywords

Hair Loss; Follicular Unit Extraction; Hair transplantation; Wound healing

Outcome Measures

Primary Outcomes (1)

• 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%)

  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

Study Arms (2)

Experimental: Treatment left

EXPERIMENTAL

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

Device: Bandage

Experimental: Treatment right

EXPERIMENTAL

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

Device: Bandage

Interventions

Bandage 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

Also known as: wound healing

Experimental: Treatment left; Experimental: Treatment right

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Able to provide informed consent
• Planning to undergo follicular unit extraction hair restoration

You may not qualify if:

• Significant medical or surgical conditions
• Unable to give informed consent
• Immunocompromised

Sponsors & Collaborators

• Pak Medical and Diagnostic Center: lead

MeSH Terms

Conditions

Alopecia

Interventions

Bandages

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Muhammad Sarfraz Khan, BSc, MBBS

  Pak Medical and Diagnostic Center

  STUDY DIRECTOR

Central Study Contacts

Jawad Jahangir, MBBS, FCPS,ABHRS

CONTACT

+923205636745; j.jabbasi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 9, 2023
• Study Start: August 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share