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

N

Nanfang Hospital, Southern Medical University

Status

Completed

Conditions

Wound Heal

Treatments

Other: HFMT cell suspension
Other: Mupirocin ointment

Study type

Interventional

Funder types

Other

Identifiers

NCT05839158
NFEC-2022-500

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

HFMT treated
Experimental group
Description:
The experimental group will receive treatment with HFMT ointment prepared in a homogenized mixture, applied once immediately after surgery to the treatment area.
Treatment:
Other: HFMT cell suspension
Mupirocin treated
Placebo Comparator group
Description:
The control group will receive treatment with Mupirocin applied once immediately after surgery to the control area.
Treatment:
Other: Mupirocin ointment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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