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A multicenter, randomized, parallel controlled trial protocol to study the efficacy and safety of collagenase ointment in the treatment of deep II degree burns and scalds

A multicenter, randomized, parallel controlled trial protocol to study the efficacy and safety of collagenase ointment in the treatment of deep II degree burns and scalds

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046971
Enrollment
Unknown
Registered
2021-06-06
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-18

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

Conditions

Deep II degree of burns and scalds

Interventions

experimental group:Collagenase ointment

Sponsors

Shanghai Changhai Hospital Burn Department
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years, gender is not limited, hospitalized 48-96 hours after injury, clinical diagnosis of deep second degree burns; (The basis for the diagnosis of burns and scald depth: the fourth-degree five-point method, for the estimation of the wound area using China 9 Division method and palm method; diagnosis and judgment are jointly completed by 2 attending physicians or above in each center.) 2. The total area of burns and scalds <= 30% TBSA (total area of the body surface), the test area is 10-100cm2, located on the limbs or trunk, the wound is clean and free of infection; choose an isolated wound as the test area as far as possible; 3. The subjects are fully informed and voluntarily sign the informed consent form, and can complete the trial and follow-up in accordance with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: 1. Those who are contraindicated or allergic to study drugs (ie, collagenase ointment and silver sulfadiazine ointment) or their ingredients; 2. Those who have clear and severe heart, brain, liver, kidney and other organ dysfunction, or related skin diseases that may cause the wound to fail to heal normally; 3. Immune dysfunction, HIV-infected patients, or patients who have been treated with radiation, hormones (systemic medication), chemotherapy, growth factors, and immunosuppressive drugs within 1 month; 4. Burns from special causes such as chemical, electrical, and radiation; 5. Critically ill patients with multiple injuries and compound injuries such as inhalation injury and trauma; 6. Those with unstable blood glucose control, such as fasting blood glucose >= 8.0mmol/L or postprandial blood glucose >= 12.0mmol/L; 7. Those who have mental illness and have no insight and cannot express accurately; 8. The assessment of pregnant women or other researchers is not suitable for participating in the research.

Design outcomes

Primary

MeasureTime frame
Mean wound healing time;

Secondary

MeasureTime frame
Mean removal time of necrotic tissue from wound surface;Total wound healing rate;Evaluation of wound inflammatory response;Wound pain assessment;Evaluation of scar hyperplasia;

Countries

China

Contacts

Public ContactXia Zhaofan, Ji Shizhao

Changhai Hospital

shizhaoji@aliyun.com+86 18621583165

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026