NCT02070809

Rapid Construction of Tissue-engineered Skin for Repairing Wounds

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 386 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 81 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
PROCEDURE	split-thickness skin graft method	This method is traditional split-thickness skin graft

Timeline

• Start date: 2013-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2014-02-25
• Last updated: 2023-12-05

Locations

1 site across 1 country: China