CP354 Biatain Ag Reimbursement study

• Research type

  Research Study

• Full title

  A prospective randomised controlled study demonstrating the clinical benefit of Biatain® Ag relative to Cutimed® Siltec® Sorbact® for the treatment of venous leg ulcers

• IRAS ID

  342982

• Contact name

  John McRobert

• Contact email

  john.mcrobert@pioneer-whlc.org

• Sponsor organisation

  Coloplast A/S

• Clinicaltrials.gov Identifier

  NCT05923749

• Duration of Study in the UK

  1 years, 4 months, 29 days

• Research summary

  This study will be conducted to demonstrate the patient benefit of Biatain® Ag relative to Cutimed® Siltec® Sorbact®, an antimicrobial wound dressing without active ingredients.

  This study will compare Biatain® Ag to commonly used wound care product Cutimed® Siltec® Sorbact®. All products in the study is CE-marked medical devices which are already available in UK. The main objective is to compare the reduction in wound area over a four weeks between the two treatment groups followed by an eight weeks follow up period. The study will also look into other aspects such as wound healing, infection management and on quality-of-life parameters defined by the Wound QoL 17-questionnaire.

  The study will recruit in total 178 adults with venous leg ulcers, that are infected or in risk of infection. The wounds must be at least 4 weeks to 5 years old. No use of antibiotics or anti-microbiel dressings are allowed prior to visit 1. Compression bandage must be used during the first four weeks. The participants will outpatients recruited through one clinic. The study is randomized controlled where half of the participants will use Biatain® Ag and half will use Cutimed® Siltec® Sorbact® for 4 weeks followed by an 8 week follow up period, where the clinical research doctor will determine standard of care treatment. Each participant will be in the study for 12 weeks. There will be 6 visits to the clinic and two phone visits. During the site visits the study team will complete different study assessments and change the dressing. The study is already enrolling participants in Denmark, Germany and USA. The study is planned to run until October 2025.

  The study is funded by Coloplast A/S ( Denmark)
  Lay summary of study results: A prospective randomised controlled study demonstrating the clinical benefit of Biatain® Ag relative to Cutimed® Siltec® Sorbact® for the treatment of venous leg ulcers

  The Biatain® Ag Reimbursement study (UK IRAS number: 342982) June 12, 2023 – January 29, 2025

  Background and Purpose
  Venous leg ulcers (VLUs) are slow to heal and affect many people, especially older adults. These wounds can be painful, become infected, and are costly to treat. Special dressings are often used to help them heal, and some of these dressings contain silver, which is known for its ability to fight bacteria. However, in Germany, new rules require that dressings with active ingredients (e.g., silver) must prove their benefit to patients to remain eligible for reimbursement by health authorities. Therefore, this study compared two types of wound dressings:

  Biatain® Ag: a foam dressing containing silver, designed to help wounds heal and prevent infection.
  Cutimed® Siltec® Sorbact®: a foam dressing that binds bacteria but does not contain active antimicrobial ingredients.

  Study Design
  The study included 179 adults with venous leg ulcers from Denmark, Germany, the UK, and the US. Participants were randomly assigned to use either Biatain® Ag or Cutimed® Siltec® Sorbact® for four weeks. After this period, all participants switched to standard, non-antimicrobial dressings for another eight weeks. The main goal (primary endpoint) was to see if Biatain® Ag was at least as good as the comparator in reducing the size of the wound after four weeks. Other goals (endpoints) included looking at how many wounds healed completely, how often dressings needed to be changed, signs of infection, and the impact on patients’ quality of life.

  Results
  Wound Healing: After four weeks, wounds treated with Biatain® Ag were reduced in size by an average of 54%, while those treated with the comparator were reduced by 44%. This means Biatain® Ag was at least as effective as the comparator, meeting the main goal of the study.
  Early Responders: More people using Biatain® Ag achieved a significant reduction in wound size (at least 40% smaller) after four weeks compared to the comparator (72% vs. 57%). This suggests Biatain® Ag may help wounds start healing faster.
  Complete Healing: After 12 weeks, about half of the wounds in both groups had healed completely, with no meaningful difference between the two dressings.
  Quality of Life: Both groups reported similar improvements in quality of life, including less pain, less wound odour, and better mobility.
  Infection and Dressing Changes: Both dressings were equally effective at reducing signs of infection. The number of dressing changes needed was similar for both groups.
  Safety: Both dressings were safe to use. There were no serious safety concerns, and the number of mild skin reactions was similar in both groups.

  Conclusion
  Biatain® Ag is a safe and effective dressing for treating venous leg ulcers. It works at least as well as a bacteria-binding dressing without active ingredients and may help wounds start healing faster. Both dressings improved patients’ quality of life and were well tolerated. No new safety issues were found. These results support the continued use and reimbursement of Biatain® Ag for people with venous leg ulcers, especially when infection is a concern.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  24/EM/0125

• Date of REC Opinion

  12 Jun 2024

• REC opinion

  Further Information Favourable Opinion