- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05646121
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Post-market Clinical Follow-up Study to Evaluate the Performance and Safety of Suprasorb® A + Ag Wound Dressing and Rope in the Treatment of Wounds at Risk of Infection and Infected Wounds
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This clinical investigation will be conducted as 3 weeks, multicentre, open, single-arm cohort study on patients presenting wounds at risk of infection or infected wounds. All wounds of the included patients will be treated with Suprasorb® A +Ag Antimicrobial Calcium Alginate Wound Dressings (and Suprasorb® A + Ag Antimicrobial Calcium Packing Rope - if required by the depth of the wound).
At inclusion visit (V1, day 0), interim visit (V2, after 10 days ±3 days) and termination visit (V3 after 21 days ±3 days or earlier; as soon as the wound is epithelialized completely) patients will have clinical examination and wound area measurements.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Claudia Feldkamp, Dr.
- Phone Number: +49 (0) 2631 99 7910
- Email: Claudia.Feldkamp@de.LRmed.com
Study Locations
-
-
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Bolesławiec, Poland
- Private Practice
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Kraków, Poland
- Private Practice
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Ostróda, Poland
- Private Practice
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Oświęcim, Poland
- Private Practice
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Pabianice, Poland
- Private Practice
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Wrocław, Poland
- Private Practice
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Łódź,, Poland
- Private Practice
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Świdnica, Poland
- Private Practice
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
The main target population of this investigation are older people. Patients will be enrolled with wounds at risk of infection and infected wounds which are: heavily exuding, superficial or deep, for:
- pressure ulcers
- arterial ulcers
- venous lower leg ulcers
- diabetic ulcers
- post-operative wounds
- skin graft and donor sites.
Description
Inclusion Criteria:
- Age ≥ 18 years
- Patient is legally capable
- Presence of a heavily exuding wound
Presence of one of the following wounds:
- pressure ulcers
- arterial ulcers
- venous lower leg ulcers
- diabetic ulcers OR
- postoperative wound
- skin graft and donor sites
- Infected wound (TILI Score ≥ 5) or a wound with risk of infection (W.A.R. Score ≥ 3)
- Wound area between 4 and 100 cm2
- It must be possible to display the entire wound area on one photo from a distance of 25-30 cm
- Patient has signed a written Informed Consent
Exclusion Criteria:
- Treatment with Suprasorb® A + Ag Antimicrobial Calcium Algi-nate Wound Dressing and Rope or any silver containing dressing or topical drug during the last 3 weeks
- Known sensitivity to Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressing and Rope or any of their components
- Malignant wounds (tumor related wounds)
- Critical limb ischemia
- Infected wounds requiring systemic antibiotic therapy at baseline visit or infected wounds with surrounding skin requiring local an-tibiotics at baseline visit and/or during study conduct.
- Severe sensitive neuropathy (9-10 points on the Neuropathie-Symptom-Score (Diagnose und Therapie der sensomotorischen diabetischen Neuropathien. Diabetes und Stoffwechsel, 11, Suppl.2 (2002))
- Planned amputation within the next 1 months
- A planned surgical operation in the region of the study wound within the next 4 weeks following inclusion
- Patient is not compliant regarding treatment of the underlying disease (e.g. compression)
- Dry wound
- Pregnancy or breast feeding
- Reliable severe malnutrition
- Patient is analphabet
- Participation in any clinical trial within the last 1 month and during participation in this study
- Legal incapacity
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
wounds at risk of infection
Ideally 71 patients with wounds at risk of infection (W.A.R. Score ≥ 3) to be included.
|
Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressings / Packing Rope are soft, conformable wound coverings with a high mannuronic acid content (mass per unit area ≥100 g/m2).
The silver impregnated calcium alginate fibres react with wound exudate or blood to form a gel which creates a moist wound environment.
The silver contained in the wound dressing has broad antimicrobial activity, including against MRSA and VRE.
Antimicrobial action (>3 log steps) associated with the ionic silver from the silver alginate fibres (1.5%) is observed in vitro after just 24 h and this remains stable for up to seven days
|
infected wounds
Ideally 28 patients with infected wounds (TILI Score ≥ 5) to be included.
|
Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressings / Packing Rope are soft, conformable wound coverings with a high mannuronic acid content (mass per unit area ≥100 g/m2).
The silver impregnated calcium alginate fibres react with wound exudate or blood to form a gel which creates a moist wound environment.
The silver contained in the wound dressing has broad antimicrobial activity, including against MRSA and VRE.
Antimicrobial action (>3 log steps) associated with the ionic silver from the silver alginate fibres (1.5%) is observed in vitro after just 24 h and this remains stable for up to seven days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combined endpoint
Time Frame: 20 months
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Change of local wound infection after 21 days of treatment with Suprasorb® A+Ag in wounds at risk of infection and infected wounds, assessed by "Therapeutical Index for Local Infections (TILI)" score. The investigator will evaluate six indirect parameters of the local wound infection:
Each present parameter will be assigned 1 point. All points will be summed up and the final score (min 0, max 6) will define the local infection status. In case the score is ≥ 5, wound is deemed to be locally infected. |
20 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of device-related adverse events (device safety)
Time Frame: 20 months
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Frequency and character severity of device deficiencies (DDs), adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs) and incidents.
|
20 months
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Change of wound bed condition, defined by the combination of the following parameters:
Time Frame: 20 months
|
|
20 months
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Change in wound-related pain, with a separate assessment of:
Time Frame: 20 months
|
|
20 months
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Change in wound-related quality of life
Time Frame: 20 months
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Change in wound-related quality of life, measured by Wound QoL Questionnaire
|
20 months
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User satisfaction
Time Frame: 20 months
|
User satisfaction, assessed by the questionnaire
|
20 months
|
Mean frequency of dressing changes
Time Frame: 20 months
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Mean frequency of dressing changes
|
20 months
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Mean time of treatment
Time Frame: 20 months
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Mean time of treatment
|
20 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Claudia Feldkamp, Dr., Lohmann & Rauscher
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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