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

Wound Heal Clinical Trial

Official title:

Evaluation of the Efficacy of Follicles-derived Microtissue Homogenate in Promoting Wound Healing After Hair Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839158
• Other study ID #: NFEC-2022-500
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

Other:
• 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.
• Mupirocin ointment
the Minoxidil ointment is evenly applied to the control group surface.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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