Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds

A Multicenter, Randomized, Controlled Clinical Trial of Tissue-engineered Skin Grafts With Autologous Scar Dermal Scaffolds for the Repair of Hypertrophic Scars

Hypertrophic scar is an inevitable outcome of wound repair. It affects the appearance and some scar contracture often leads to joint dysfunction.Patients have low quality of life, long treatment cycle, heavy social burden and high medical costs.Skin grafting is currently the gold standard for scar repair.However, there are often insufficient skin sources, easy to scar recurrence, lack of skin accessory organs.The application of composite skin graft can reduce the recurrence rate of scar healing and relieve the deficiency of skin source.However, its survival rate is not high, and acellular allogeneic dermal scaffolds are expensive, heavy medical burden.Therefore, how to effectively repair the wound surface after surgical excision of scar is the main problem to be solved urgently.

Dermal loss is the main cause of unsatisfactory scar repair and recurrence.The previous clinical study of the research group found that the application of autologous epidermal basal cells and autologous skin graft obtained in real time during the operation could effectively improve the survival rate of skin graft in the treatment of wound surface (Brit J Surg, 2015).Furthermore, it is suggested that the application of autologous scar dermal scaffolds can achieve the control of skin damage in the skin harvesting area and the orthotopic transplantation of autologous scar tissue dermal scaffolds, which can effectively reduce the economic burden of patients.Therefore, the researchers wondered whether the construction of tissue-engineered skin orthotopic transplantation with autologous epidermal basal cells and autologous scar dermal scaffold combined with autologous scar dermal scaffolds to repair the wound after scar resection could improve the survival rate of skin graft and reduce scar recurrence.To this end, we plan to carry out multi-center, prospective, randomized, controlled clinical trials, aiming at proposing more effective surgical treatment guidelines for the repair of hypertrophic scar, improving the survival rate of composite skin graft, and solving the current clinical problems of hypertrophic scar repair.

Study Overview

• Status: Recruiting
• Conditions: Scar
• Intervention / Treatment: Procedure: Tissue-engineered skin grafts of autologous scar dermal scaffolds

• Study Type: Interventional
• Enrollment (Anticipated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ZHU JIAYUAN; Phone Number: 8276 86-20-87755766; Email: zhujiay@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital, Sun Yat-sen University
      • Contact: Jiayuan Zhu, PI; Phone Number: 8276 86-20-87755766; Email: zhujiay@mail.sysu.edu.cn
      • Sub-Investigator: Zhicheng Hu, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

The patient is diagnosed as hypertrophic scar and needs surgical repair; The scar size was 10cm2 to 200cm2, and the site was not limited; Patients with stable vital signs and tolerable operation indicated by routine examination; Patients in good mental state, can follow the doctor's advice, regular return; Those whom the researchers considered unsuitable for inclusion; Patients have participated in this study at any time in the past; Those whom the researchers considered unsuitable for inclusion; Patients have participated in this study at any time in the past.

Exclusion Criteria:

Those who did not meet the inclusion criteria were found after the selected subjects; The follow-up time after inclusion was less than 2 times, and the objective efficacy could not be evaluated (but the adverse reactions could be evaluated); Subjects who violate protocol requirements.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tissue engineering method; The thickness of scar tissue in the middle of the dermis is removed by a roller cutter with a thickness of about 0.01 -- 0.02mm. After cleaning, the dermis can be used for punching and mesh drawing in the dermal rolling machine.Autologous epidermal basal cell suspension was prepared according to the description of autologous epidermal basal cell extraction box.The size of the remaining skin should be the same as the wound surface. After washing with normal saline, the wet yarn should be wrapped for later use.The autogenous scar dermal scaffold was prepared and transplanted onto the wound surface. The autoepidermal basal cells prepared were sprayed or coated between the mesh and the dermal scaffold. Autologous skin slices were transplanted onto the wound surface and fixed with pressure bandaging.	Procedure: Tissue-engineered skin grafts of autologous scar dermal scaffolds; scar excision. The thickness of scar tissue in the middle of scar is removed with a roller cutter and the thickness is about 0.01 -- 0.02mm.; take autologous skin slices of the patient with an electric skin knife, cut out a small piece of skin, and prepare autologous epidermal basal cell suspension for use;The rest of the skin should be the same size as the wound.; the prepared autogenous scar dermal stent was grafted onto the scar resection wound surface, and the prepared autoepidermal basal cells were sprayed between the mesh and on the dermal stent, and autologous skin slices were grafted onto the wound surface and fixed with pressure bandaging;; after the operation, the outer dressing should be changed regularly according to the conventional treatment, and the wound surface condition should be observed and recorded according to the experimental scheme.
Active Comparator: Conventional therapy; Autologous skin was grafted onto the wound surface and fixed with pressure bandage	Procedure: Tissue-engineered skin grafts of autologous scar dermal scaffolds; scar excision. The thickness of scar tissue in the middle of scar is removed with a roller cutter and the thickness is about 0.01 -- 0.02mm.; take autologous skin slices of the patient with an electric skin knife, cut out a small piece of skin, and prepare autologous epidermal basal cell suspension for use;The rest of the skin should be the same size as the wound.; the prepared autogenous scar dermal stent was grafted onto the scar resection wound surface, and the prepared autoepidermal basal cells were sprayed between the mesh and on the dermal stent, and autologous skin slices were grafted onto the wound surface and fixed with pressure bandaging;; after the operation, the outer dressing should be changed regularly according to the conventional treatment, and the wound surface condition should be observed and recorded according to the experimental scheme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing rate	the percentage of subjects that achieved complete wound closure,complete wound closure is defined as skin conplete reepithelialization without drainage or dressing requirements.	postsurgery week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound reducing rate	the rate of wound reducing based on week 4 after surgery	postsurgery week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
recrrence rate	the incidence of ulcer recurrence at postsurgery month 6	postsurgery month 6

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Director: ZHU JIAYUAN, Professor, Chief Physician

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: 2018002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No