Repairing scars with tissue-engineered skin grafts
A Multicenter, Randomized, Controlled Clinical Trial of Tissue-engineered Skin Grafts With Autologous Scar Dermal Scaffolds for the Repair of Hypertrophic Scars
This study is testing a new way to treat stubborn scars using skin grafts made from the patient's own cells to see if it can improve healing and reduce costs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | N/A to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04389164 on ClinicalTrials.gov |
What this trial studies
This study focuses on treating hypertrophic scars, which can lead to reduced quality of life and joint dysfunction. It aims to utilize tissue-engineered skin grafts made from autologous scar dermal scaffolds to improve scar repair outcomes. The approach seeks to address the limitations of current skin grafting methods, such as insufficient skin sources and high recurrence rates. By using the patient's own cells, the study hopes to enhance the survival rate of the grafts and reduce medical costs associated with scar treatment.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with hypertrophic scars requiring surgical repair, with scar sizes between 10cm² and 200cm².
Not a fit: Patients with scars outside the specified size range or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve scar healing and reduce the recurrence of hypertrophic scars.
How similar studies have performed: While similar approaches have been explored, this specific method using autologous dermal scaffolds is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Zhu Jiayuan
- Email: zhujiay@mail.sysu.edu.cn
- Phone: 86-20-87755766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.