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Self-controlled multicentre clinical study to evaluate the efficacy and safety of recombinant human collagen hydrogel for donor site wounds in skin grafts.

Development of standardized clinical trial for in-situ regeneration of intelligent biomaterials and establishment of follow-up evaluation system

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037910
Enrollment
Unknown
Registered
2020-09-04
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recombinant human collagen gel dressing was applied to the donor wound during skin grafting.

Interventions

A:recombinant human collagen hydrogel

Sponsors

Department of Burns, First Affiliated Hospital of Naval Medical University (formerly Department of Burns, Shanghai Changhai Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged from 18 to 60 years old; 2. Patients who are going to take autologous skin grafting surgery in clinic; 3. For patients with total wound area less than 5% (estimated by palm method), the target wound was between 5cm × 5cm and 10cm x 20cm, and the wound location was both lower limbs; 4. Patients who agreed to participate in the study and signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. The patients with diabetes mellitus were judged as poor glycemic control by doctors after regular clinical treatment; 2. Patients with severe malnutrition and albumin 38.5 degree C or WBC > 12x10^9/L; 4. Patients with severe systemic infection who need systemic antibiotics treatment; 5. Patients with tumor, radiotherapy or chemotherapy; 6. Patients complicated with cardiovascular, liver, kidney and blood system and other serious primary diseases and mental diseases; 7. Patients who are known to have allergic history or allergic constitution (allergic to 2 or more allergens) to ingredients or other chemical structures similar to this product and reference substance; 8. Pregnant or lactating women and patients with family planning; 9. Patients who have participated in other clinical studies within one month before enrollment; 10. Patients who are considered unsuitable for clinical study by other researchers.

Design outcomes

Primary

MeasureTime frame
Days of wound healing;

Countries

China

Contacts

Public ContactZhu Shihui

(formerly Department of Burns, Shanghai Changhai Hospital)

doctorzhushihui@163.com+86 13901971974

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026