NCT04389164 Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds
| NCT ID | NCT04389164 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Condition | Scar |
| Study Type | INTERVENTIONAL |
| Enrollment | 226 participants |
| Start Date | 2019-03-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 226 participants in total. It began in 2019-03-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
ZHU JIAYUAN
STUDY DIRECTOR
Professor, chief physician
Frequently Asked Questions
Who can join the NCT04389164 clinical trial?
This trial is open to participants of all sexes, up to 80 Years, studying Scar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04389164 currently recruiting?
Yes, NCT04389164 is actively recruiting participants. Contact the research team at zhujiay@mail.sysu.edu.cn for enrollment information.
Where is the NCT04389164 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04389164 clinical trial?
NCT04389164 is sponsored by First Affiliated Hospital, Sun Yat-Sen University. The principal investigator is ZHU JIAYUAN at Professor, chief physician. The trial plans to enroll 226 participants.