Evaluation of the Effect of HFMT in Promoting Donor-site Wound Healing

NCT05839158 | Completed

• 1 other identifier: NFEC-2022-500
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Autologous hair transplantation involves follicle extraction, trimming, and implantation. Follicle trimming improves efficiency and postoperative appearance, resulting in the discarded tissue known as hair follicle-derived microtissue (HFMT). In a clinical case, HFMT homogenate was applied to the FUE donor area wound, resulting in reduced pain, relief from itching, and faster healing compared to conventional treatment. This study aims to compare the effects of HFMT on FUE donor area wound healing.

Conditions

Wound Heal

Keywords

hair transplantation

Outcome Measures

Primary Outcomes (1)

• Changes in the area of the wound at the donor site

  Using a dermatoscope, randomly select 3 fields of view, measure the area of all wounds in the field of view, and calculate the average value of the deviation between the wound area and the initial wound area.

  post op days 3, 5, 7, 14 and post op weeks 4, 6, 8, 12, 16, 24

Study Arms (2)

HFMT treated

EXPERIMENTAL

The experimental group will receive treatment with HFMT ointment prepared in a homogenized mixture, applied once immediately after surgery to the treatment area.

Other: HFMT cell suspension

Mupirocin treated

PLACEBO COMPARATOR

The control group will receive treatment with Mupirocin applied once immediately after surgery to the control area.

Other: Mupirocin ointment

Interventions

HFMT cell suspension OTHER

Perform FUE autologous hair transplantation on the patient according to the guidelines and standard procedures. During the procedure, a hollow punch is used to individually punch out follicular units from the donor area. The epidermis, some dermis tissue, sebaceous glands, and surrounding tissue of the follicular units are separated and removed before the remaining follicular tissue is implanted into the recipient area. The separated tissue is trimmed with surgical scissors to create a cell suspension. After completion of the procedure, the HFMT cell suspension is evenly applied to the treatment group surface. Double vaseline gauze is used to cover all donor areas and is then wrapped with sterile dry gauze with moderate pressure.

HFMT treated

Mupirocin ointment OTHER

the Minoxidil ointment is evenly applied to the control group surface.

Mupirocin treated

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-60 years who underwent FUE autologous hair transplantation.
• The patient's liver and kidney function were normal, and the serum protein level before surgery was normal.

You may not qualify if:

• Patients with a history of smoking.
• Those suffering from diseases that affect wound healing, such as diabetes or hyperglycemia.
• Those with abnormal blood sugar.
• Abnormal cardiopulmonary function.
• There are foci of infection in or near the surgical area.
• Scar hyperplasia or scar constitution.
• Those with a history of neuralgia.
• The patient took immunosuppressants, cytostatics, and hormonal anticoagulants before surgery and antibiotics.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510080, China

Location

Study Officials

• Zhiqi Hu, MD, PhD

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 3, 2023
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: These data will continue to be presented in the paper after its publication.
• Access Criteria: People with access to journal databases can access the relevant data of this study.

Locations

CN (1)