Skip to content

Clinical trial of efficacy and safety of Silver Ion Antibacterial Functional Dressing in the treatment of deep second degree burn wounds

Clinical trial of efficacy and safety of Silver Ion Antibacterial Functional Dressing in the treatment of deep second degree burn wounds

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049814
Enrollment
Unknown
Registered
2021-08-10
Start date
2019-12-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Deep second degree burn wounds

Interventions

Experimental group:Silver Ion Antibacterial Functional Dressing
Control group:Atrauman Ag dressing

Sponsors

Wuhan Thrid Hospital-Tongren Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 65 years; (2) hospitalized within 72 hours after injury; (3) Subjects with total burn and burn area <30% of total body surface area (TBSA) have deep second degree burns, and all deep second degree burns should be regarded as observation wounds as far as possible, except the wounds on face, eyes, hands, feet, perineum, genitals and other special parts should not be regarded as observation wounds; The wound may be free of infection or infected, but there should be no signs of serious infection, systemic infection or systemic infection. Classification by depth: 4 degrees and 5 points method; methods of estimation was Chinese Rule of Nines Method and Palm Method; (4) The cause of burn is thermal burn; Including hydrothermal (water, soup, oil, etc.), steam, high temperature gas, flame, hot metal liquid or solid (such as molten steel, steel ingot); (5) The subject is fully informed and voluntarily signs the written informed consent.

Exclusion criteria

Exclusion criteria: (1) The causes of burn were electrical discharge burn, chemical burns, and radiation burn; (2) Industrial silver contact history (such as jewelry, photography development, silver welding, etc.); (3) The wound had been treated with other silver-containing substances before admission; (4) Poor compliance or life-threatening and unable to complete the course of treatment; (5) Severe immune system diseases, serious complications or systemic infection; (6) Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney or hematopoietic system, mental disease or diabetes mellitus; (7) Patients with a history of liver function or renal function injury; (8) Allergic or allergic to silver; (9) women who are pregnant or preparing to be pregnant and who are breastfeeding; (10) Screening of subjects who have participated in any clinical trial within the previous 3 months; (11) May not be able to complete the study for other reasons or the investigator believes that the study should not be included.

Design outcomes

Primary

MeasureTime frame
Wound area;Healing time;wound infection;

Secondary

MeasureTime frame
Safety index;Blood silver levels;The silver level in urine;General reaction;Topical irritation, swelling, pain, color change;

Countries

China

Contacts

Public ContactXie Weiguo

Wuhan Thrid Hospital-Tongren Hospital of Wuhan University

wgxie@hotmail.com+86 18071085225

Outcome results

None listed

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