Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Must be taking: Silver based therapy
Must not be taking: Immunosuppressives, Antibacterials
Disqualifiers: Cancer, Heart failure, Diabetes, others
No Placebo Group
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?This trial investigates if Cutimed Sorbact, a special wound dressing, can reduce bacteria in venous leg ulcers. It targets patients with these hard-to-heal wounds by using a dressing that attracts and removes bacteria to promote healing. Cutimed Sorbact is an absorbent bacteria-binding foam dressing used in wound healing and has been studied for its impact on patients' quality of life.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive medications, you may not be eligible to participate.
What data supports the effectiveness of the treatment Cutimed Siltec Sorbact for venous leg ulcers?
Research shows that Cutimed Siltec Sorbact dressings are effective in managing venous leg ulcers by absorbing wound fluid, reducing infection, and improving the surrounding skin condition, which also positively impacts patients' quality of life.
12345Is the dressing safe for use in humans?
The Cutimed Sorbact range of dressings is considered safe for long-term use with minimal risk of side effects, as it binds bacteria to its surface for removal without killing them.
12346How does the treatment Cutimed Sorbact differ from other treatments for venous leg ulcers?
Cutimed Sorbact is unique because it uses a hydrophobic (water-repelling) fatty acid coating to bind and remove bacteria from wounds, which helps manage infections without relying on traditional antimicrobial agents like silver. This approach can improve wound healing and patient comfort by effectively absorbing wound exudate (fluid) and reducing infection-related complications.
12347Eligibility Criteria
Adults with venous leg ulcers present for at least a month, sized 2-100 cm². Participants must not have certain medical conditions like autoimmune diseases or uncontrolled diabetes, and women of childbearing age should use contraception. Ulcers should be treated previously with silver therapy and show no signs of infection.Inclusion Criteria
I have been treated with silver-based therapy for my leg ulcer.
Subject is able to comprehend all study related procedures and adhere to study schedule
I have a deep leg ulcer that does not expose muscle or bone.
+10 more
Exclusion Criteria
Subject has known allergy to any of the materials used in the study
My ulcer showed signs of infection needing oral antibiotics between my first and second visit.
My ulcer is not caused by poor vein function, according to my doctor.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the Acticoat or Cutimed Sorbact intervention for 6 weeks
6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
Participant Groups
The study is testing the effectiveness of Cutimed Sorbact versus Acticoat in reducing bacterial load in venous leg ulcers. It will involve participants who meet specific health criteria to ensure accurate results on how well these treatments work.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cutimed® Sorbact®Experimental Treatment1 Intervention
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Group II: Acticoat®Active Control1 Intervention
Participants in this group will receive the Acticoat intervention for 6 weeks.
Cutimed Sorbact is already approved in European Union, United States, Australia for the following indications:
🇪🇺 Approved in European Union as Cutimed Sorbact for:
- Venous leg ulcers
- Diabetic foot ulcers
- Pressure ulcers
- Chronic wounds
🇺🇸 Approved in United States as Cutimed Sorbact for:
- Venous leg ulcers
- Diabetic foot ulcers
- Pressure ulcers
- Chronic wounds
🇦🇺 Approved in Australia as Cutimed Sorbact for:
- Venous leg ulcers
- Diabetic foot ulcers
- Pressure ulcers
- Chronic wounds
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
BSN Medical IncIndustry Sponsor
References
Clinical performance and quality of life impact of an absorbent bacteria-binding foam dressing. [2021]The aim of this prospective multicentre observational study was to assess the clinical performance and safety of Cutimed® Siltec® Sorbact® absorbent bacteria-binding foam dressing in wound healing and its impact on patients' quality of life (QoL). The study was conducted under routine clinical conditions in 5 study sites in Germany and Poland. Each patient with a venous leg ulcer (VLU) or a diabetic foot ulcer (DFU) was observed for 28 days (initial visit and close-out visit, as well as 3 control visits). An assessment of QoL of the patient was undertaken before and after the study. Sixty-two patients were included in the statistical analysis. Clinicians rated the following assessment parameters in relation to Cutimed Siltec Sorbact dressings as 'very good' to 'good': wearing comfort (rated by the patient), application and removal, exudate absorption with or without compression and fluid retention capacity with or without compression and infection management. The use of Cutimed Siltec Sorbact dressing was beneficial in absorbing wound exudate (chi-square=28.45, P value<0.001), reduction of the viscosity of wound exudate (chi-square=25.63, P value<0.001), and there were more intact, less macerated, red and oedematous wound surroundings. There was also a 9% decrease in the number of infected wounds at the close-out visit. Analysis of the Wound-QoL measures demonstrated a reduction in the perception of performance parameters associated with wound infection. It can therefore be deduced that the use of Cutimed Siltec Sorbact was effective in wound management and had positive implications for patients' QoL.
Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study). [2023]Label="AIM" NlmCategory="OBJECTIVE">To determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact® ) against a silver dressing (Aquacel® Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health-related quality of life, level of pain, and time to complete healing.
Innovative solutions to daily challenges. [2010]Today's clinicians face the daunting task of finding the best cost-effective and clinically appropriate solutions to ever complex wounds. The right combination of dressings help to maintain a moist environment, successfully manage exudate levels and reduce complications. This article seeks to explore the fundamental issues behind successful dressing choice and the new products that are becoming available for use as tools in the ongoing wound care initiative. In particular, the antimicrobial dressing Cutimed® Sorbact® used in conjunction with the exudate management properties of Cutimed® Siltec® and Cutisorb® Ultra by BSN medical will be examined with the commencement of three clinical evaluations.
Hydrogel-impregnated dressings for graft fixation: a case series. [2015]Infection is the second most common cause of graft loss after skin grafting. Cutimed Sorbact is a range of dressings coated with a hydrophobic fatty acid that irreversibly binds to the bacterial surface and mechanically removes bacteria from the wound. The dressing is a hydrogel-impregnated material, which prevents wounds from drying. Here, we report on cases in which we used the gel instead of the widely used petrolatum gauze or paraffin gauze in a tie-over dressing for the fixation of grafted skin.
Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review. [2022]Dialkylcarbomoyl chloride (DACC)-coated dressings (Leukomed Sorbact and Cutimed Sorbact) irreversibly bind bacteria at the wound surface that are then removed when the dressing is changed. They are a recent addition to the wound care professional's armamentarium and have been used in a variety of acute and chronic wounds. This systematic review aims to assess the evidence supporting the use of DACC-coated dressings in the clinical environment.
Safe, long-term management of bioburden that helps promote healing Evidence review of DACC technology. [2015]Unlike common antimicrobial dressings, the Cutimed Sorbact range does not kill pathogens, but instead binds them to its surface, so they can be safely removed at dressing change. As a result, it can be used long term with minimal risk of side effects. This supplement describes the evidence base on the efficacy of DACC technology.
[A new generation of dressings in the treatment of leg ulcers]. [2006]Current methods of topical treatment of leg ulcers are reviewed. Leg ulcers are chronic wounds in a trophically altered tissue that affects the healing capacity. Complete healing requires prolonged and rather expensive treatment and the patient is often disabled during this period. The conventional methods of treatment of leg ulcers, including various compresses, ointments, pastes and other topical drugs, that may possess a considerable sensitizing potential, are to an increasing extent replaced by updated therapy consisting in the use of a new generation of dressings. The latter include a number of materials that have been developed on the basis of recent knowledge of wound healing, such as hydrogels, hydrocolloids, xerogels, hydropolymer dressings, polyurethane foam sheets, alginate dressings, and non-adherent, non-woven cloth impregnated with silver and activated charcoal. The selection of the available materials must depend on the character and stage of the healing process. Each group of dressings exerts specific effects and none of them can recommended generally for the treatment of any types of ulceration. A brief survey of indications is given for each group to avoid their abuse.