Cellulose membrane dressing for hard-to-heal venous leg ulcers

Topical application of a bacterial cellulose membrane (Bioprocess®) versus a silver-containing calcium alginate dressing (Suprasorb A + Ag) for chronic venous leg ulcers: a randomised controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN80037348

Enrollment

100

Registered

2025-12-30

Start date

2022-02-01

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Chronic venous leg ulcers (VLU) Skin and Connective Tissue Diseases

Interventions

Arm 1 (Intervention): Bacterial cellulose membrane dressing (Bioprocess®

Biofil, Curitiba, Brazil) applied to the ulcer after saline irrigation, extending ~1 cm beyond wound margins, covered with sterile gauze

compression bandaging applied (target pressure 25–35 mmHg). Weekly physician review

ulcer area measured every 7 days by planimetry. Arm 2 (Control): Silver-containing calcium alginate dressing (Suprasorb A + Ag

Lohmann & Rauscher) applied after saline irrigation, covered with sterile gauze

compression bandaging as above (25–35 mmHg). Dressing replaced daily until healing

weekly physician review

ulcer area measured every 7 days by planimetry. Co-interventions (both arms): Standard wound cleansing (saline), debridement as clinically indicated, and standard pharmacotherapy for chronic venous di

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults (=18 years) 2. Presence of a chronic venous leg ulcer (VLU) on the lower limb, confirmed by Doppler ultrasonography 3. Ankle–brachial index (ABI) within the acceptable/normal range 4. Eligible for standard compression therapy and outpatient follow-up 5. Prior standard care (e.g., compression and conventional dressings) without complete healing before enrolment 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Non-venous ulcers (e.g., arterial, diabetic foot, vasculitic, malignant ulcers) 2. Clinically significant arterial disease / ABI 1.3 3. Active severe wound infection requiring systemic antibiotics at baseline 4. Known allergy to dressing components (bacterial cellulose, alginate, silver) 5. Pregnancy or breastfeeding 6. Inability to provide informed consent or comply with compression therapy/follow-up

Countries

Poland

Contacts

Public ContactKinga;Ewa Spyrka;Rojczyk

;

ikingaxd@gmail.com;e.rojczyk@ujd.edu.pl+48 501193857;+48 605466076

Outcome results

None listed

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