Clinical trial NCT05839158: Evaluation of the Effect of HFMT in Promoting Donor-site Wound Healing
Official title: Evaluation of the Efficacy of Follicles-derived Microtissue Homogenate in Promoting Wound Healing After Hair Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Keywords: hair transplantation
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in the area of the wound at the donor site
timeFrame: post op days 3, 5, 7, 14 and post op weeks 4, 6, 8, 12, 16, 24
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Zhiqi Hu, MD, PhD
role: STUDY_CHAIR
References: