Creating tissue-engineered skin to heal wounds quickly
Multicenter Clinical Randomized Controlled Trials on Rapid Construction of Tissue-engineered Skin for Repairing Wounds
This study is testing a new way to heal wounds faster using special lab-made skin to see if it works better than the usual skin grafts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 386 (estimated) |
| Ages | N/A to 81 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT02070809 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a new method for repairing wounds using tissue-engineered skin technology. The approach involves grafting skin over a human acellular dermal matrix scaffold, which allows for rapid reconstruction of skin structure and function without the need for cell culturing. The study will compare the efficacy and safety of this innovative method against traditional split-thickness skin grafts in a prospective randomized controlled multicenter trial. The goal is to improve wound healing outcomes and enhance the quality of the skin post-repair.
Who should consider this trial
Good fit: Ideal candidates include individuals requiring skin grafts for wounds sized between 3 cm² and 100 cm², who are under 81 years old and in stable health.
Not a fit: Patients with severe uncontrolled diseases, acute infections, or those with allergic reactions to enzymes may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly improve wound healing and restore skin function more effectively than current treatments.
How similar studies have performed: While tissue-engineered skin technology has shown promise in preliminary studies, this specific approach is novel and has not been extensively tested in a multicenter trial setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects who need to skin graft to repair the wound * Subjects signed the informed consent in the day of the age of not more than 81 years old (for minors, legal guardian should be signed) * Stable vital signs, regular examination showed that subjects could tolerate surgery * Subjects' mental state are good, could follow the doctor's advice, visit on a regular basis * Understanding and willing to participate in this clinical trial and signed informed consent * All women subjects must agree to take effective contraceptive measures in the six months study period, and without pregnancy before participate in the treatment * No other serious diseases conflicts with the trail * Wound size between 3 cm2 and 100 cm2, no limited to location Exclusion Criteria: * Allergic constitution of enzyme * Severe uncontrolled disease or acute systemic infections and complication with other serious heart, lung disease, encephalopathy and other organs or have a rapid progress or terminal disease * Subjects with mental illness * Subjects could not cooperate with the clinical trial personnel to finish trials * Existing disease (malignant tumor, autoimmune disease) or require the use of drugs (high-dose glucocorticoids, which is defined as accepting 40 mg or more daily prednisone or prednisone amount, period of two weeks or more) will affect the healing of the wound * For HIV positive patients, clinical diagnosis of patients with AIDS or the screening phase of neutrophil count (ANC) absolutely \< 1000 cells/mm3 * Subjects could not tolerate surgery * Subjects are unlikely to survive in the study period * The investigators think that who should not be included * Subjects are in or participated in other clinical researchers over the past 12 weeks * Subjects are participated in this trial at any time in the past
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Jiayuan Zhu, doctor — First Affiliated Hospital, Sun Yat-Sen University
- Study coordinator: Jiayuan Zhu, PI
- 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.