Rapid Construction of Tissue-engineered Skin for Repairing Wounds

NCT ID: NCT02070809

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2024-12-31

Brief Summary

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.

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.

Conditions

Wound

Keywords

wound; tissue-engineered skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

tissue-engineered skin method

Intervention Type: PROCEDURE

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

split-thickness skin graft method

This method is traditional split-thickness skin graft

Group Type: ACTIVE_COMPARATOR

split-thickness skin graft method

Intervention Type: PROCEDURE

This method is traditional split-thickness skin graft

Interventions

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

Intervention Type: PROCEDURE

split-thickness skin graft method

This method is traditional split-thickness skin graft

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhu Jiayuan

Professor, vice director of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiayuan Zhu, doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiayuan Zhu, PI

Role: CONTACT

Phone: 86-20-87755766

Email: zhujiay@mail.sysu.edu.cn

Facility Contacts

Jiayuan Zhu, PI

Role: primary

Other Identifiers

2013001

Identifier Type: -

Identifier Source: org_study_id