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

June 29, 2023 updated by: Nanfang Hospital, Southern Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Nanfang Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Placebo Comparator: Mupirocin treated
The control group will receive treatment with Mupirocin applied once immediately after surgery to the control area.
Other: Mupirocin ointment
the Minoxidil ointment is evenly applied to the control group surface.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the area of the wound at the donor site
Time Frame: post op days 3, 5, 7, 14 and post op weeks 4, 6, 8, 12, 16, 24
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital, Southern Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zhiqi Hu, MD, PhD, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2022-500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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