Actively Recruiting

Phase Not Applicable
Age: 0 - 80Years
All Genders
NCT04389164

Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds

Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2020-05-15

226

Participants Needed

1

Research Sites

461 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds

Who Can Participate

Age: 0 - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with hypertrophic scar needing surgical repair
  • Scar size between 10cm squared and 200cm squared at any site
  • Stable vital signs and can tolerate surgery based on routine examination
  • Mentally well and able to follow doctor's advice and attend regular follow-ups
Not Eligible

You will not qualify if you...

  • Does not meet the inclusion criteria
  • Follow-up visits fewer than two times after inclusion, preventing evaluation of effectiveness
  • Violates study protocol requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510080

Actively Recruiting

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Research Team

Z

ZHU JIAYUAN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds | DecenTrialz