Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    226
  • sponsor
    First Affiliated Hospital, Sun Yat-Sen University
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Updated on 19 February 2024
See if I qualify
deficiency
treatment guidelines
hypertrophy
adverse reactions
scar
skin damage
hypertrophic scar

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.

Details
Condition Scar
Age 80years or below
Treatment Tissue-engineered skin grafts of autologous scar dermal scaffolds
Clinical Study IdentifierNCT04389164
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

The patient is diagnosed as hypertrophic scar and needs surgical repair; The
scar size was 10cm2 to 200cm2, and the site was not limited; Patients with
stable vital signs and tolerable operation indicated by routine examination
Patients in good mental state, can follow the doctor's advice, regular return
Those whom the researchers considered unsuitable for inclusion; Patients have
participated in this study at any time in the past; Those whom the researchers
considered unsuitable for inclusion; Patients have participated in this study
at any time in the past

Exclusion Criteria

Those who did not meet the inclusion criteria were found after the selected
subjects; The follow-up time after inclusion was less than 2 times, and the
objective efficacy could not be evaluated (but the adverse reactions could be
evaluated); Subjects who violate protocol requirements
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