Pressure UlcerNCT05646121
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
An observational study of Pressure Ulcer and Arterial Ulcers, run by Lohmann & Rauscher at 8 sites in Poland.
Trial summary
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb® A + Ag wound dressing and rope within the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Arterial Ulcers, Venous Leg Ulcer
- What is being tested?
- Suprasorb® A + Ag wound dressing and rope
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 8 sitesPoland
- Study dates
- 13 Sep 2022to 5 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years
- Patient is legally capable
- Presence of a heavily exuding wound
- Presence of one of the following wounds:
- pressure ulcers
- arterial ulcers
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- 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
Who cannot join
- 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))
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Poland8 sites
Private Practice
Bolesławiec
Private Practice
Krakow
Private Practice
Lodz
Private Practice
Ostróda
Private Practice
Oświęcim
Private Practice
Pabianice
Private Practice
Swidnica
Private Practice
Wroclaw
About this study
Official title: 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
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb® A + Ag wound dressing and rope within the certified indications and under the conditions of routine use.
Read the 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.
- Conditions
- Pressure Ulcer, Arterial Ulcers, Venous Leg Ulcer, Diabetic Ulcers, Surgical Wound, Skin Graft
- Being tested
- Suprasorb® A + Ag wound dressing and rope
- Medical subject headings
- Pressure Ulcer, Varicose Ulcer, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprasorb® A + Ag wound dressing and ropeDevice
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
| Study group | Role | What they receive |
|---|---|---|
| wounds at risk of infection | Ideally 71 patients with wounds at risk of infection (W.A.R. Score ≥ 3) to be included. Receives: Device: Suprasorb® A + Ag wound dressing and rope | |
| infected wounds | Ideally 28 patients with infected wounds (TILI Score ≥ 5) to be included. Receives: Device: Suprasorb® A + Ag wound dressing and rope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint
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:
- erythema to surrounding skin
- heat
- oedema, induration or swelling
- spontaneous pain or pressure pain
- stalled wound healing
- increase and/or change in colour or smell of exudate
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.
Measured: 20 months
Secondary outcomes (7)
Rate of device-related adverse events (device safety)
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.
Measured: 20 months
Change of wound bed condition, defined by the combination of the following parameters:
- Wound shift (reduction change of distribution of necrotic, fibrin and granulation tissue in % of the wound area), measured by W.H.A.T. (Wound Healing Analyzing Tool)
- Wound shift (change of distribution of necrotic, fibrin and granulation tissue in % of the wound area), assessed visually by the investigators
- Change in grade of exudation (from very high to none)
- Change in type of exudate (from purulent to clear)
- Change of peri-wound skin condition (presence or absence of erosion, maceration, dryness /scaling, edema, redness)
- Wound size reduction over time measured by W.H.A.T. (Wound Healing Analyzing Tool)
- Achieved healing rate, measured as a proportion of patients having complete wound epithelization after 20 months of treatment to the whole study population
Measured: 20 months
Change in wound-related pain, with a separate assessment of:
- pain by dressing removal measured by NRS (numeric-rating scale from 0 to 10, where 0=no pain, 10=worst pain imaginable)
- change in general wound related pain, measured by NRS (numeric-rating scale from 0 to 10, where 0=no pain, 10=worst pain imaginable)
Measured: 20 months
Change in wound-related quality of life
Change in wound-related quality of life, measured by Wound QoL Questionnaire
Measured: 20 months
User satisfaction
User satisfaction, assessed by the questionnaire
Measured: 20 months
Mean frequency of dressing changes
Mean frequency of dressing changes
Measured: 20 months
Mean time of treatment
Mean time of treatment
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start13 Sep 2022
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lohmann & Rauscher
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Feldkamp, Dr., Study director, Lohmann & Rauscher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646121
- Sponsor's protocol ID
- 2021-02
- Status last verified
- Jan 2024
- First submitted
- 19 Sep 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05646121
- Acronym / sponsor ID
- 2021-02
- Conditions
- Pressure Ulcer, Arterial Ulcers, Venous Leg Ulcer, Diabetic Ulcers, Surgical Wound, Skin Graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Lohmann & RauscherIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb® A + Ag wound dressing and rope within the certified indications and under the conditions of routine use.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wounds at risk of infection | – | Device: Suprasorb® A + Ag wound dressing and ropeIdeally 71 patients with wounds at risk of infection (W.A.R. Score ≥ 3) to be included. |
| infected wounds | – | Device: Suprasorb® A + Ag wound dressing and ropeIdeally 28 patients with infected wounds (TILI Score ≥ 5) to be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- Age ≥ 18 years
- Patient is legally capable
- Presence of a heavily exuding wound
- Presence of one of the following wounds:
- Infected wound (TILI Score ≥ 5) or a wound with risk of infection (W.A.R. Score ≥ 3)
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprasorb® A + Ag wound dressing and ropeSuprasorb® 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 | Device | infected wounds, wounds at risk of infection |
Primary outcome
Combined endpoint
Time frame: 20 months
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: * erythema to surrounding skin * heat * oedema, induration or swelling * spontaneous pain or pressure pain * stalled wound healing * increase and/or change in colour or smell of exudate 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.
7 secondary outcomes
Rate of device-related adverse events (device safety)
Time frame: 20 months
Change of wound bed condition, defined by the combination of the following parameters:
Time frame: 20 months
Change in wound-related pain, with a separate assessment of:
Time frame: 20 months
Change in wound-related quality of life
Time frame: 20 months
User satisfaction
Time frame: 20 months
Mean frequency of dressing changes
Time frame: 20 months
Mean time of treatment
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Feldkamp, Dr. study director
Lohmann & Rauscher
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer and Arterial Ulcers, run by Lohmann & Rauscher at 8 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.