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

Primary Purpose

Wound Heal

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HFMT cell suspension
Mupirocin ointment
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal focused on measuring hair transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Nanfang Hospital of Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HFMT treated

Mupirocin treated

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2023
Last Updated
June 29, 2023
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05839158
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal
Keywords
hair transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFMT treated
Arm Type
Experimental
Arm Description
The experimental group will receive treatment with HFMT ointment prepared in a homogenized mixture, applied once immediately after surgery to the treatment area.
Arm Title
Mupirocin treated
Arm Type
Placebo Comparator
Arm Description
The control group will receive treatment with Mupirocin applied once immediately after surgery to the control area.
Intervention Type
Other
Intervention Name(s)
HFMT cell suspension
Intervention Description
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
Intervention Name(s)
Mupirocin ointment
Intervention Description
the Minoxidil ointment is evenly applied to the control group surface.
Primary Outcome Measure Information:
Title
Changes in the area of the wound at the donor site
Description
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.
Time Frame
post op days 3, 5, 7, 14 and post op weeks 4, 6, 8, 12, 16, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiqi Hu, MD, PhD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The age of the participants and photographs of the skin under the dermatoscope will be presented in the paper
IPD Sharing Time Frame
These data will continue to be presented in the paper after its publication.
IPD Sharing Access Criteria
People with access to journal databases can access the relevant data of this study.

Learn more about this trial

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

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