An interventional study of Tissue-engineered skin grafts of autologous scar dermal scaffolds in Scar, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
Among 41 studies in Cicatrix with a site in China — 9 open to participants now, 9 under way, none of them phase 3. Cicatrix · China.
Among the 41 studies in Cicatrix with a site in China, this one is the 2nd largest by planned enrollment of the 33 interventional ones that give a count, is one of 4 that started in 2019, is one of 22 with no phase, and was the 19th registered.
612 studies on the registry are indexed under Cicatrix; 115 are open to participants now.
Browse Cicatrix studies →9 of the 41 studies in Cicatrix with a site in China are open now. Recruiting first, the newest first:
Peking University Third Hospital · Sites in China
Ages 20–50
Mabwell (Shanghai) Bioscience Co., Ltd. · Sites in China
Ages 18+
Women's Hospital School Of Medicine Zhejiang University · Sites in China
Ages 18+ · Women only
LIAO Peng · Sites in China
Ages 3–6
Chinese Medical Association · Sites in China
Ages 18–70
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 69 Cicatrix studies recruiting now, 34 (49%) set no upper age limit and 31 (45%) stop at 75 or younger; 11 take children under 18; 16 take healthy volunteers.
This study: Up to 80 Years · all sexes · no healthy volunteers.
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41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 2
First in 2011; this study’s year is marked. 4 started in 2019.
This study's planned enrollment of 226 is above the median of 40 across 513 interventional studies indexed under Cicatrix.
Median enrollment 50 across the 33 interventional studies, 119 across the 8 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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3 of 41 have an industry lead sponsor. The 10 most frequent:
First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 162 studies on the registry; 54 are open to participants now.
First Affiliated Hospital, Sun Yat-Sen University has 2 studies filed under Cicatrix — fewer than ten, so there is no comparison to draw.
4 of the studies in Cicatrix with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07576608Mabwell (Shanghai) Bioscience Co., Ltd.A Phase II Study of 9MW3811 in Patients With Pathological Scar | 2026-12 |
| NCT07608094Women's Hospital School Of Medicine Zhejiang UniversityThe Treatment Outcomes of Cesarean Scar Pregnancy | 2026-12-31 |
| NCT07620769CLASSYS Inc.Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars | 2027-03 |
| NCT07849010Peking University Third HospitalDisposable Noninvasive Skin Closure for Promoting Postoperative Wound Healing and Preventing Surgical Skin Scarring | 2027-06-30 |
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Among the 41 studies in Cicatrix with a site in China, from their registry updates:
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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.
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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.
The thickness of scar tissue in the middle of the dermis is removed by a roller cutter with a thickness of about 0.01 -- 0.02mm. After cleaning, the dermis can be used for punching and mesh drawing in the dermal rolling machine.Autologous epidermal basal cell suspension was prepared according to the description of autologous epidermal basal cell extraction box.The size of the remaining skin should be the same as the wound surface. After washing with normal saline, the wet yarn should be wrapped for later use.The autogenous scar dermal scaffold was prepared and transplanted onto the wound surface. The autoepidermal basal cells prepared were sprayed or coated between the mesh and the dermal scaffold. Autologous skin slices were transplanted onto the wound surface and fixed with pressure bandaging.
Procedure: Tissue-engineered skin grafts of autologous scar dermal scaffolds
Autologous skin was grafted onto the wound surface and fixed with pressure bandage
Procedure: Tissue-engineered skin grafts of autologous scar dermal scaffolds
1. scar excision. The thickness of scar tissue in the middle of scar is removed with a roller cutter and the thickness is about 0.01 -- 0.02mm. 2. take autologous skin slices of the patient with an electric skin knife, cut out a small piece of skin, and prepare autologous epidermal basal cell suspension for use;The rest of the skin should be the same size as the wound. 3. the prepared autogenous scar dermal stent was grafted onto the scar resection wound surface, and the prepared autoepidermal basal cells were sprayed between the mesh and on the dermal stent, and autologous skin slices were grafted onto the wound surface and fixed with pressure bandaging; 4. after the operation, the outer dressing should be changed regularly according to the conventional treatment, and the wound surface condition should be observed and recorded according to the experimental scheme.
healing rate
the percentage of subjects that achieved complete wound closure,complete wound closure is defined as skin conplete reepithelialization without drainage or dressing requirements.
Time frame: postsurgery week 4
wound reducing rate
the rate of wound reducing based on week 4 after surgery
Time frame: postsurgery week 4
recrrence rate
the incidence of ulcer recurrence at postsurgery month 6
Time frame: postsurgery month 6
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2019 (actual). Primary completion is estimated for Dec 2025, 81 months after the start.
Of 173 non-industry interventional studies with no phase under Cicatrix, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's planned 81 months is above that.
Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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First Affiliated Hospital, Sun Yat-Sen University →