Skip to content

Clinical study of acid fibroblast growth factor combined with artificial dermis in the treatment of skin defect wounds

Clinical study of acid fibroblast growth factor combined with artificial dermis in the treatment of skin defect wounds

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088353
Enrollment
Unknown
Registered
2024-08-16
Start date
2022-02-09
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Full-thickness skin defect wounds

Interventions

Test group:aFGF+AD implantation is performed to observe the wound, and thin STSG grafting is performed once AD is fully vascularized.
Control group:Solvent+AD implantation is performed to observe the wound, and thin STSG grafting is performed once AD is fully vascularized.

Sponsors

Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 65 Years

Inclusion criteria

Inclusion criteria: Those who meet the following four criteria are included: 3 years old = age =65 years old; relatively flat full-thickness skin defect wound with well-vascularized wound base and edge tissue; wound located in the limbs or trunk, and the wound with an area =36cm^2 and the width was =4cm; Patients and/or their guardians understood and signed the informed consent form.

Exclusion criteria

Exclusion criteria: The exclusion criteria include: Extensive deep burn with open wound more than 10% total body surface area (TBSA) or severe systemic condition; Malnutrition, plasma albumin < 30 g/L, or hemoglobin < 9 g/L; Wounds with local infection, more necrotic tissue, poor blood supply to the wound base, sinus tract, or tendon or bone exposure; Radiation ulcer wound; Pressure ulcer or diabetic ulcer with transcutaneous oxygen pressure of skin around the wound less than 40 mmHg; Allergic to collagen or chondroitin sulfate, or allergic diseases; Pregnant or lactating women; Those requiring ongoing treatment with oral corticosteroids; Patients with poorly controlled diabetes or severe cardiovascular, hepatic, renal or hematological diseases; People with mental disorders or epilepsy; Any condition considered by the investigator to be likely to increase the risk to the subject or affect the evaluation of efficacy.

Design outcomes

Primary

MeasureTime frame
Grafting interval time;

Secondary

MeasureTime frame
Survival quality of skin graft;Survival rate of skin graft;Wound healing time of recipient site;Rate of healing wound contraction;Modified Vancouver Scar Scale score;

Countries

China

Contacts

Public ContactGuodong Song

Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)

sgd.zxyy@163.com+86 135 8902 1927

Outcome results

None listed

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