Role of Bandage After FUE Hair Transplantation

Hair Loss/Baldness Clinical Trial

Official title:

Bandage Versus No-Bandage After Follicular Unit Extraction Hair Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05984862
• Other study ID #: PMDC-23-07-6745
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: August 2023
• Source: Pak Medical and Diagnostic Center
• Contact: Jawad Jahangir, MBBS, FCPS,ABHRS
• Phone: +923205636745
• Email: j.jabbasi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Hair Loss/Baldness

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pak Medical and Diagnostic Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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