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Clinical trial on the safety and efficacy of polymer oxygen-supplying alginate for wound repair in donor sites after autologous skin grafting

Clinical trial on the safety and efficacy of polymer oxygen-supplying alginate for wound repair in donor sites after autologous skin grafting

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105686
Enrollment
Unknown
Registered
2025-07-09
Start date
2023-07-07
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

burns split-thickness skin graft donor site

Interventions

Test group:the polymer oxygenated alginate dressing
Control group:the sterile Vaseline gauze

Sponsors

Affiliated Hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18–70 years (inclusive of 18 and 70 years). 2. Patients aged 18–70 years who require autologous skin grafting and are scheduled to have medium-thickness skin grafts taken. 3. The longest side of the donor site wound does not exceed 18 cm, and the maximum area is no more than 200 cm²; medium-thickness skin grafts will be harvested . 4. Willing to participate and able to complete this study

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. If a patient meets any of the following criteria before surgery, they are not eligible for inclusion: 1) Patients who will use more than one donor site; 2) Patients whose donor site is scalp skin. 2. Diseases that may affect the healing of the donor site wound: 1) Bleeding disorders, thrombocytopenia, active bleeding, shock, or visceral injury; severe coagulation dysfunction (PT, APTT >1.5 times the upper limit of normal); 2) Uncontrolled diabetes: glycated hemoglobin (HbA1c) >8% at screening, fasting blood glucose =11.1 mmol/L or random blood glucose =13.6 mmol/L during the screening period; 3) Peripheral vascular disease (capillary fragility, presence of venous or arterial disease directly affecting the donor site to be treated, vasculitis); 4) Known or suspected malignancy; 5) Autoimmune diseases, such as lupus, multiple sclerosis; 6) Sepsis; 7) Positive for human immunodeficiency virus infection or a history of congenital immunodeficiency; 8) Chronic kidney disease or renal insufficiency; 9) Patients who have been on long-term immunosuppressive agents, antineoplastic drugs, and chronic corticosteroid therapy. 3. Preoperative diagnosis of cellulitis in burn wounds. 4. Poor compliance or patients in critical condition who cannot complete the course of treatment. 5. Critically ill patients on mechanical ventilation who are unable to sign an informed consent form or participate in subjective assessments. 6. Patients without normal skin sources and with severe hypertrophic scars in the donor site that are unsuitable for skin harvesting. 7. Patients who cannot tolerate the materials related to this study. 8. Any of the following hematologic abnormalities: 1) Hemoglobin (Hb) 1.5×ULN; 2) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3×ULN; 3) ?-Glutamyl transferase (?-GT) >2.5×ULN; 4) Alkaline phosphatase (Alk-P) >2.5×ULN; 5) Serum albumin 1.5×ULN. 10. Donor site wounds (DSW) that the investigators consider to be in an active skin area or highly sensitive skin condition. 11. Patients who are currently receiving or have received systemic or inhaled corticosteroids or immunosuppressive agents within 4 weeks prior to study entry. 12. Patients who are pregnant or breastfeeding, or who are in a protected population (e.g., prisoners, mentally incapacitated individuals). 13. Patients who have participated in other clinical trials within one month before signing the informed consent form. 14. Other situations where the investigator deems the patient unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Complete wound healing time at donor site ;

Secondary

MeasureTime frame
Visual Analogue Scale (VAS) Score for Donor Site Wound Pain;Postoperative wound exudation at the donor site;

Countries

China

Contacts

Public ContactGuozhong Lyu

Affiliated Hospital of Jiangnan University Burn & Trauma Treatment Center

luguozhong@jiangnan.edu.cn+86 138 0618 3990

Outcome results

None listed

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