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Efficacy and safety of compound sulfadiazine zinc gel in treating second-degree burn wounds: A prospective, multicenter, randomized, positive drug-controlled clinical trial

Efficacy and safety of compound sulfadiazine zinc gel in treating second-degree burn wounds: A prospective, multicenter, randomized, positive drug-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105583
Enrollment
Unknown
Registered
2025-07-07
Start date
2025-07-31
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

Second degree burn wound

Interventions

Experimental group:Conventional treatment + Compound sulfadiazine zinc gel
Control group:Conventional treatment + silver sulfadiazine cream

Sponsors

Chengdu City Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 1~80 years old, gender is not limited; 2. Superficial second degree or deep second degree burn wounds, injury factors and injured sites are not limited; 3. See a doctor within 1 week after burn, The wound area was (1-20) %TBSA. 4. Conscious, normal intelligence, able to cooperate with relevant treatment and visit; 5. Obtain informed consent and signature from patient or guardian.

Exclusion criteria

Exclusion criteria: 1. Combined inhalation injury, Burn shock and lung, kidney, liver and other organ damage after burn; 2. Patients with systemic infectious diseases, blood diseases, coagulation disorders; or clear severe heart, brain, liver, kidney and other organ dysfunction; 3. Complicated with diabetes, stroke paralysis, malnutrition and other chronic diseases resulting in poor health or related skin diseases affecting skin wound healing; 4. Patients with immune dysfunction, HIV infection, or radiation, hormones (systemic drugs), chemotherapy, growth factors and immunosuppressive drugs within 1 month; 5. Persons with mental disorders and alcoholics and drug addicts; 6. Hypersensitivity to any component of the drug used in the trial; 7. Neonatal, pregnant and lactating women, or recent birth plans, and other circumstances considered inappropriate by the investigator for participation in the study; 8. Patients who participated in other clinical trials within the last 3 months.

Design outcomes

Primary

MeasureTime frame
Wound healing time: burn wound complete epithelialization healing time, unit: days. ;

Secondary

MeasureTime frame
Wound healing rate: Wound healing rate of burn wounds at the end of 4 weeks observation period ;Wound healing rate =(wound area before treatment-wound area after treatment)/wound area before treatment ×100% ;Length of hospital stay: length of hospital stay of burn patients in days; ;Positive rate of bacterial culture: evaluation before treatment, 7±1d, 14±1d, 28+1d after treatment; bacterial culture of burn wound exudate. ;Pain and itching: evaluation before treatment, 7±1d, 14±2d, 28+3d after treatment; ;Scar: evaluation of patients with healed wounds at 3 months ±7 days and 6 months ±7 days after burn; ;Use of antibiotics;

Countries

China

Contacts

Public ContactHuang Zhiyong

Chengdu City Second People's Hospital

2219506373@qq.com+86 139 8180 1197

Outcome results

None listed

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