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

NCT ID: NCT05839158

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

The process of autologous hair transplantation involves three steps: FUE follicle extraction, follicle trimming, and follicle implantation. The purpose of follicle trimming is to improve the efficiency of follicle implantation and enhance the immediate postoperative aesthetic appearance. Therefore, during the follicle trimming process, the sebaceous glands and above-mentioned epidermis, partial dermis tissue, and surrounding tissue of the follicles are usually separated and discarded, and the remaining follicle tissue is implanted into the recipient area. The investigator collectively refers to the discarded tissue as hair follicle-derived microtissue (HFMT). In a clinical case, The investigator accidentally discovered that if the HFMT obtained from the follicular unit extraction (FUE) method was collected, cut into pieces, and made into tissue homogenate, and then the HFMT homogenate was used to cover the FUE donor area wound, the patient reported reduced postoperative pain and some relief from skin itching. Additionally, compared to conventionally treated wounds, the wound in the donor area healed faster. Based on these findings, this study aims to compare the effects of HFMT on the healing of FUE donor area wounds.

Conditions

Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HFMT treated

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

Group Type: EXPERIMENTAL

HFMT cell suspension

Intervention Type: 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.

Mupirocin treated

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

Group Type: PLACEBO_COMPARATOR

Mupirocin ointment

Intervention Type: OTHER

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

Interventions

HFMT cell suspension

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.

Intervention Type: OTHER

Mupirocin ointment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiqi Hu, MD, PhD

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NFEC-2022-500

Identifier Type: -

Identifier Source: org_study_id