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A multicenter, randomized, parallel-controlled clinical study of collagenase ointment in the treatment of acute traumatic wounds

A multicenter, randomized, parallel-controlled clinical study of collagenase ointment in the treatment of acute traumatic wounds

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076576
Enrollment
Unknown
Registered
2023-10-12
Start date
2024-02-15
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Patients with acute abrasion, contusion, and laceration

Interventions

Experimental group: Collagenase Ointment Group:Cleaning the wound with iodophor and saline solution. If the wound is deep, 2% lidocaine could be used to the wound for anesthesia, followed by hydrogen
Control group: Standard of Care:Clean ing the wound with iodophor and saline. If the wound is deep, 2% lidocaine could be used to the wound for anesthesia. followed by hydrogen peroxide to remove fore

Sponsors

The Fourth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, gender not limited; 2. Patients with abrasions, contusions, or lacerations that have not been treated with drugs, chemicals, or other substances within 24 hours after injury; 3. Wounds do not require surgical sutures; 4. Skin wound area between 6-100 square centimeters, with wound classification of II or III degree; (II degree: Injury involves the epidermis and various layers of the dermis, with obvious irregular defects, necrosis, ischemia, and can be manifested as bleeding, swelling, bruising, and tenderness. III degree: Injury involves the entire skin layer, reaching the subcutaneous adipose layer, without concurrent injury and exposure of nerves, large blood vessels, tendons, muscles, and bones. Clinical manifestations include local skin soft tissue defects and bleeding, swelling, bruising, and tenderness.); 5. Subjects are fully informed and informed consent documents to complete the study and follow-up according to the study protocol.

Exclusion criteria

Exclusion criteria: 1. Subjects with contraindications or allergies to the investigational drug or its ingredients; 2. Subjects with concurrent systemic infectious diseases, hematological disorders, or coagulation dysfunction; 3. Subjects with severe organ dysfunction of the heart, brain, liver, or kidney; 4. Subjects with chronic diseases such as diabetes, stroke sequelae, or other conditions that may affect skin wound healing and those who are using corticosteroids chronically or have related skin diseases that may cause delayed wound healing; 5. Subjects with immunodeficiency, HIV infection, or who have received radiation therapy, systemic hormone therapy, chemotherapy, growth factors, or immunosuppressive drugs within the past month; 6. Subjects with poor nutritional status; 7. Subjects with skin defects caused by non-acute forces such as compression, radiation, or tuberculosis; 8. Pregnant women (or women who are planning to become pregnant during the trial), or breastfeeding women; 9. Subjects with obvious scar hyperplasia; 10. Subjects who have participated in other clinical trials within the past 3 months, or who are currently participating in other clinical trials; 11. Subjects with mental illness, confusion, coma, lack of self-awareness, or inability to express themselves accurately; 12. Subjects who, based on the investigator's assessment, are not suitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
The coverage rate of epithelial tissue on the wound surface on the 7th day of treatment;

Secondary

MeasureTime frame
Wound healing rate;Average wound healing time;Wound inflammatory response assessment;Pain VAS score;Patient satisfaction;Vancouver Scar Scale;

Countries

China

Contacts

Public ContactZhao Xiaodong

The Fourth Medical Center of PLA General Hospital

zxd63715@126.com+86 133 6651 3525

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026