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Evaluation of effectiveness and safety of antibacterial dressing in treatment of chronic wounds

Evaluation of effectiveness and safety of antibacterial dressing containing polyhexamethylene biguanide in treatment of chronic wounds

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190210042676N49
Enrollment
30
Registered
2025-12-22
Start date
2025-12-21
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Skin lesions. Changes in skin texture

Interventions

Intervention group: Using a dressing with a healing and antibacterial gel containing polyhexamethylene biguanide, produced by Taba Zist Polymer Company (Treetta), for a duration of 4 weeks, with dress

Sponsors

Taba Zist Polymer Company (Treetta)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 18-65 years old men and women People with chronic wounds (such as diabetic foot ulcers and burns) Willingness to participate in the study and agreement to follow the treatment protocol, attend the required follow-up visits, and sign the informed consent form The wound must be chronic, meaning that at least 4 weeks have passed since its onset, but no more one year The presence of at least one wound and no more than two, meeting the appropriate wound classification criteria excluding interdigital areas-and without bone involvement (Wagner grade 1 and 2 for diabetic ulcers, and superficial or deep second-degree burns

Exclusion criteria

Exclusion criteria: Symptomatic chronic cardiopulmonary disease Patients with immunodeficiency pregnancy, breastfeeding or the intention to become pregnant during the study

Design outcomes

Primary

MeasureTime frame
Changes in wound size compared to the initial wound size using an antibacterial dressing containing polyhexamethylene biguanide (PHMB). Timepoint: Before the intervention and weekly for 4 weeks. Method of measurement: Checkered paper.

Secondary

MeasureTime frame
Percentage of patients who achieved complete healing. Timepoint: Before the intervention and weekly for 4 weeks. Method of measurement: Counting the responders.;Measurement of pain intensity. Timepoint: Before the intervention and weekly for 4 weeks. Method of measurement: Using VAS grading.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 21 8896 0880

Outcome results

None listed

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