NCT06173908

Autologous Epidermal Cell Treat for Nonhealing Postoperative Wound

Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 85 Years
• Healthy volunteers: Not accepted

Summary

Postoperative incision healing (Postoperative incision non - ranging) occurred in the surgical incision more than 2 weeks after the operation is still not healing wounds. At present, direct suture, autologous skin graft transplantation, conventional dressing change and negative pressure wound therapy are still the first-line treatment options for postoperative wound nonunion. However, the wound healing time is long and the wound healing rate is low. Autologous epidermal basal cell suspension is derived from the basal layer of the epidermis and contains 1-10% epidermal stem cells. Therefore, we plan to carry out a multi-center, prospective randomized controlled clinical trial, aiming to verify whether this technique can promote wound healing.

Detailed description

Postoperative incision healing (Postoperative incision non - ranging) occurred in the surgical incision more than 2 weeks after the operation is still not healing wounds, show the incision infection, effusion, hemorrhage, empyema, skin lesions and skin defect. It has a high morbidity and the treatment cycle is long, the social and economic burden is heavy. At present, direct suture, autologous skin graft transplantation, conventional dressing change and negative pressure wound therapy are still the first-line treatment options for postoperative wound nonunion. However, the wound healing time is long and the wound healing rate is low. Therefore, how to improve the wound healing rate is an urgent problem to be solved. The present study indicated that the disturbance of wound microenvironment was the main reason for the wound healing. Autologous epidermal basal cell suspension is derived from the basal layer of the epidermis and contains 1-10% epidermal stem cells. Therefore, we plan to carry out a multi-center, prospective randomized controlled clinical trial, aiming to verify whether this technique can promote wound healing.

Conditions

• Healing Wound

Interventions

Type	Name	Description
PROCEDURE	cell treatment	Autologous epidermal basal cells were used to repair nonhealing postoperative wound
PROCEDURE	control treatment	anyother treatments except autologous epidermal basal cells were used to repair nonhealing postoperative wound

Timeline

• Start date: 2018-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-12-18
• Last updated: 2023-12-18

Locations

1 site across 1 country: China