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Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
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.
Official title: A Multicenter, Randomized, Controlled Clinical Trial of Tissue-engineered Skin Grafts With Autologous Scar Dermal Scaffolds for the Repair of Hypertrophic Scars
Key Details
Gender
All
Age Range
Any - 80 Years
Study Type
INTERVENTIONAL
Enrollment
226
Start Date
2019-03-01
Completion Date
2027-12-31
Last Updated
2020-05-15
Healthy Volunteers
No
Conditions
Interventions
Tissue-engineered skin grafts of autologous scar dermal scaffolds
1. 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. 2. 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. 3. 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; 4. 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.
Locations (1)
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China