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A multicentre, randomized controlled trial for sodium carboxymethyl cellulose silver dressing in the treatment of chronic wounds

A multicentre, randomized controlled trial for sodium carboxymethyl cellulose silver dressing in the treatment of chronic wounds

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034215
Enrollment
Unknown
Registered
2020-06-28
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

Chronic wound

Interventions

experimental group:Using sodium carboxymethyl cellulose silver dressing (Aquacel ? Ag + Extra) for chronic wound dressing
control group:Using generation product on the hydrophilic fiber containing silver dressing (Aquacel AgExtra)

Sponsors

The First Affiliated Hospital of Sun Yat sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The age of the patients who signed the informed consent was 364 days from 18 to 80 years old; 2. The patients diagnosed as chronic wounds can not recover more than 1 month after standard treatment; 3. The size of wound window is about 10-25cm2, and the specific site is unlimited, without bone invasion and bone exposure; 4. The patients with stable vital signs, no obvious symptoms of systemic infection and serious organ diseases, whose regular examination (blood routine, biochemical) shows that they can accept treatment; 5. The serum creatinine of patients with renal insufficiency was less than 3.0mg/dl; 6. The blood glucose of diabetic patients was well controlled, and the HbA1c was less than 12%; 7. Patients with ankle brachial index (ABI) between 0.7 and 1.3; 8. The patient is in good mental state, can follow the doctor's advice, and has regular follow-up; 9. Patients who understand and are willing to participate in this clinical trial and provide signed informed consent; 10. Patients without other serious diseases in conflict with the program.

Exclusion criteria

Exclusion criteria: Any of the following conditions shall not be included in this test: 1. Patients with serious uncontrolled diseases or advanced diseases, with serious heart, lung, brain and other serious organ diseases; 2. The existing diseases will affect the patients with wound healing (severe anemia (HB < 60g / L), hypoproteinemia (ALB < 25g / L), malignant tumor, autoimmune connective tissue disease, etc.); 3. Patients with radiation ulcer and malignant lesions at the ulcer; 4. Patients who are receiving radiotherapy or chemotherapy or taking hormone or immunosuppressant; 5. Patients with mental diseases or those who cannot cooperate with clinical trial personnel to complete relevant examinations; 6. Those who are allergic to the product and its related ingredients; 7. The researcher thinks it is not suitable to be included; 8. Being pregnant or breastfeeding, or planning to be pregnant or breastfeeding during the study period; 9. Those who are participating in or have participated in other clinical studies in the past 12 weeks; 10. Patients participated in the study at any time in the past.

Design outcomes

Primary

MeasureTime frame
Wound healing rate (28d);

Countries

China

Contacts

Public ContactJiayuan Zhu

The First Affiliated Hospital of Sun Yat sen University

zhujiay@mail.sysu.edu.cn+86 13802751558

Outcome results

None listed

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