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Deshitai new hydrogel foam dressing for the treatment of partical thickness burns of the skin real world research

Deshitai new hydrogel foam dressing for the treatment of partial thickness burns of the skin real world research

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058572
Enrollment
Unknown
Registered
2022-04-11
Start date
2021-09-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Second degree burn

Interventions

Experimental group:Dewetai new hydrogel foam dressing
Control group:Conservative dressing change therapy

Sponsors

The First Affiliated Hospital of PLA Navy Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 1 to 60 years (including boundary value), no gender limitation; 2. Patients admitted to hospital within 24 hours after injury were clinically diagnosed as second-degree burns and burn depth based on the four-degree and five-point method. For wound area estimation, Chinese nine-point method and palm method were used; 3. The total area of burn and scald is no more than 15%TBSA (total body surface area), and the subject area is 10-80cm^2, located in the limbs or trunk, with clean wound surface and no infection; Isolated wound surface was selected as the test area as far as possible; 4. The cause of burn is thermal burn; Including hot liquid (water, soup, oil, etc.), steam, high temperature gas, flame, hot metal liquid or solid (such as molten steel, steel ingot), etc.; 5. The subject is fully informed and the informed consent is signed voluntarily or by the guardian.

Exclusion criteria

Exclusion criteria: 1. Those who have contraindications or allergies to the study drugs or their ingredients; 2. Patients with clear and severe organ dysfunction, such as heart, brain, liver and kidney; 3. Severe wound contamination or infection of patients; 4. Immune dysfunction, HIV infected patients, or patients who have received radiation, hormone (systemic drug), chemotherapy, growth factors, or immunosuppressive drugs within 1 month; 5. Burns due to chemical, electrical, radiation and other special reasons; 6. Critically ill patients with inhalation injury, trauma and other multiple injuries; 7. Unstable blood glucose control, such as fasting blood glucose >=8.0mmol/L or postprandial blood glucose >=12.0mmol/L; 8. Those who suffer from mental disorders and have no self-awareness and cannot express themselves accurately; 9. Maternal or other investigator assessments are not appropriate for participating investigators.

Design outcomes

Primary

MeasureTime frame
Mean healing time;

Secondary

MeasureTime frame
Rate of wound deepening;Total wound healing rate;Wound pain assessment;Wound inflammation assessment;Evaluation of scar hyperplasia;

Countries

China

Contacts

Public ContactXia Zhaofan
shizhaoji@aliyun.com+86 18621583165

Outcome results

None listed

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