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Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds

Primary Purpose

Scar

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tissue-engineered skin grafts of autologous scar dermal scaffolds
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tissue engineering method

Conventional therapy

Arm Description

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.

Autologous skin was grafted onto the wound surface and fixed with pressure bandage

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

wound reducing rate
the rate of wound reducing based on week 4 after surgery

Full Information

First Posted
April 29, 2020
Last Updated
May 11, 2020
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04389164
Brief Title
Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds
Official Title
A Multicenter, Randomized, Controlled Clinical Trial of Tissue-engineered Skin Grafts With Autologous Scar Dermal Scaffolds for the Repair of Hypertrophic Scars
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tissue engineering method
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Autologous skin was grafted onto the wound surface and fixed with pressure bandage
Intervention Type
Procedure
Intervention Name(s)
Tissue-engineered skin grafts of autologous scar dermal scaffolds
Intervention Description
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.
Primary Outcome Measure Information:
Title
healing rate
Description
the percentage of subjects that achieved complete wound closure,complete wound closure is defined as skin conplete reepithelialization without drainage or dressing requirements.
Time Frame
postsurgery week 4
Secondary Outcome Measure Information:
Title
wound reducing rate
Description
the rate of wound reducing based on week 4 after surgery
Time Frame
postsurgery week 4
Other Pre-specified Outcome Measures:
Title
recrrence rate
Description
the incidence of ulcer recurrence at postsurgery month 6
Time Frame
postsurgery month 6

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZHU JIAYUAN
Phone
86-20-87755766
Ext
8276
Email
zhujiay@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZHU JIAYUAN
Organizational Affiliation
Professor, chief physician
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Zhu, PI
Phone
86-20-87755766
Ext
8276
Email
zhujiay@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Zhicheng Hu, doctor

12. IPD Sharing Statement

Plan to Share IPD
No

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Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds

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