Rapid Construction of Tissue-engineered Skin for Repairing Wounds

Multicenter Clinical Randomized Controlled Trials on Rapid Construction of Tissue-engineered Skin for Repairing Wounds

A wound comprises a break in epithelial continuity and disruption of structure and function of underlying tissues, the treating and repairing is always a great challenge in clinical practice. The complex healing process make the wound easy to get a tendency of nonhealing and result in a heavy burden of life quality. Nowadays surgical repairing is still the main method, but there was still no effective and satisfy outcomes. Because none of the treatments could repair skin both on structure and function. Now the investigators provide a quick and effective method to rebuilt complete structure and function of the skin based on tissue-engineered skin technology. To further test the efficacy and safety of this new method, the investigators propose a prospective randomized controlled multicenter trial to compare this method with traditional skin graft.

Study Overview

• Status: Recruiting
• Conditions: Wound
• Intervention / Treatment: Procedure: tissue-engineered skin method; Procedure: split-thickness skin graft method

Detailed Description

A wound comprises a break in epithelial continuity and disruption of structure and function of underlying tissues, the treating and repairing is always a great challenge in clinical practice. The complex healing process make the wound easy to get a tendency of nonhealing and result in a heavy burden of life quality. Nowadays surgical repairing is still the main method, such as traditional split-thickness skin graft, flap transplantation or tissue-engineered substitute transplantation. However, none of these methods could have effective and satisfy outcomes. Because none of these treatments could repair skin on both structure and function. Therefore, as a new treating technology the tissue-engineered skin has been widely used recently and shows good response. As a consequence, the investigators provide a quick and effective method to rebuilt complete structure and function of the skin based on tissue-engineered skin technology. This method is composite of skin grafting over human acellular dermal matrix scaffold the investigators used before with skin basal cell as seed cells, moreover it was finished in the surgery without culturing the cells and could greatly reduce the time. To further test the efficacy and safety of this new method, the investigators propose a prospective randomized controlled multicenter trial to compare this method with traditional skin graft. If this method could actually increase wound take rate, improve the skin quality and restore skin function in some extent, it should resolve the problem of wound repair to a large extent.

• Study Type: Interventional
• Enrollment (Estimated): 386
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Zhu, PI; 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 81 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects who need to skin graft to repair the wound
• Subjects signed the informed consent in the day of the age of not more than 81 years old (for minors, legal guardian should be signed)
• Stable vital signs, regular examination showed that subjects could tolerate surgery
• Subjects' mental state are good, could follow the doctor's advice, visit on a regular basis
• Understanding and willing to participate in this clinical trial and signed informed consent
• All women subjects must agree to take effective contraceptive measures in the six months study period, and without pregnancy before participate in the treatment
• No other serious diseases conflicts with the trail
• Wound size between 3 cm2 and 100 cm2, no limited to location

Exclusion Criteria:

• Allergic constitution of enzyme
• Severe uncontrolled disease or acute systemic infections and complication with other serious heart, lung disease, encephalopathy and other organs or have a rapid progress or terminal disease
• Subjects with mental illness
• Subjects could not cooperate with the clinical trial personnel to finish trials
• Existing disease (malignant tumor, autoimmune disease) or require the use of drugs (high-dose glucocorticoids, which is defined as accepting 40 mg or more daily prednisone or prednisone amount, period of two weeks or more) will affect the healing of the wound
• For HIV positive patients, clinical diagnosis of patients with AIDS or the screening phase of neutrophil count (ANC) absolutely < 1000 cells/mm3
• Subjects could not tolerate surgery
• Subjects are unlikely to survive in the study period
• The investigators think that who should not be included
• Subjects are in or participated in other clinical researchers over the past 12 weeks
• Subjects are participated in this trial at any time in the past

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tissue-engineered skin method; This method is composite of skin grafting over human acellular dermal matrix scaffold the investigators used before with skin basal cell as seed cells, moreover it was finished in the surgery without culturing the cells	Procedure: tissue-engineered skin method; This method is composite of skin grafting over human acellular dermal matrix scaffold the investigators used before with skin basal cell as seed cells, moreover it was finished in the surgery without culturing the cells
Active Comparator: split-thickness skin graft method; This method is traditional split-thickness skin graft	Procedure: split-thickness skin graft method; This method is traditional split-thickness skin graft

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 complete 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
recurrence 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: Principal Investigator: Jiayuan Zhu, doctor, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 22, 2014
• First Submitted That Met QC Criteria: February 22, 2014
• First Posted (Estimated): February 25, 2014

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: wound; tissue-engineered skin
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2013001