Prospective, open‐label, multicenter, single‐arm, post‐marketing study to assess the performance and safety of Vliwasorb® Pro
Organizational Data
- DRKS-ID:
- DRKS00031365
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-02-27
- Last update in DRKS:
- 2023-11-09
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The objectives of the PMCF study is to confirm the performance of Vliwasorb® Pro and to collect additional safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Vliwasorb® Pro wound dressing within the certified indications and under the conditions of routine use.
Brief summary in scientific language
The objectives of the PMCF study is to confirm the performance of Vliwasorb® Pro and to collect additional safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Vliwasorb® Pro wound dressing within the certified indications and under the conditions of routine use.
Health condition or problem studied
- Free text:
- wound healing
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- the study is single-arm. The clinical examination is carried out for 21 days (± 3 days). Vliwasorb® Pro is used for 3 dressing changes (≙ 4 times) or up to a maximum of 21 days (± 3 days). A total of 5 visits are planned.
Endpoints
- Primary outcome:
- Condition of the periwound skin (maceration, erythema [redness]) Primary Endpoints The condition/assessment of the skin surrounding the wound (maceration, erythema/redness) measured using a 5-point Likert scale (none, minimal, moderate, severe, very severe) after 21 days serves as the primary performance parameter. Visit 1: Inclusion visit (Day 1), first application of Vliwasorb® Pro • Visit 2: First dressing change, second application of Vliwasorb® Pro • Visit 3: Second dressing change, third application of Vliwasorb®Pro • Visit 4: Third dressing change, fourth application of Vliwasorb®Pro • Visit 5: Final Evaluation (Day 21 ± 3 days)
- Secondary outcome:
- Wound bed condition (percentage of necrotic, fibrinous, granulating and epithelizing tissue) Grade of exudation Odour Patients´ pain upon dressing removal Dryness of the periwound skin Safety Secondary Endpoints • Degree of exudation • Integrity of the skin around the wound • Condition of the skin around the wound (dermatitis, inflammation, dryness) • Patient pain when the patient removes the bandage • Condition of the wound bed (necrotic, fibrinous, granulating and epithelial tissue) • Wound odor • Wound infection • Atraumatic dressing removal • Safety: Device Defects (DDs), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Product Effects (ADEs), Serious Adverse Product Effects (SA-DEs)
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Helios-Klinikum Leisnig
- Doctor's practice Waidhaus
- Doctor's practice Mönchengladbach
- Doctor's practice Willich
Recruitment period and number of participants
- Planned study start date:
- 2023-02-27
- Actual study start date:
- 2023-03-27
- Planned study completion date:
- 2024-11-27
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 135
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Patients with acute and chronic wounds - Wounds with moderate to very high amounts of exudate - Non‐infected wounds, wounds at risk of infection, infected wounds - All indications listed in the Vliwasorb® Pro IFU - Arterial‐venous (“mixed”) leg ulcerations with a relevant, but not critical arterial proportion - Patient over 18 years of age - Patient has signed written Informed Consent Form - Patient agreed to comply with study treatment and planned study visits
Exclusion Criteria
Use of Vliwasorb® Pro wound dressing is contraindicated according to the current IFU: - Known hypersensitivity to the product or its components. - Not for use in tunnel‐forming wound pockets, as the product may expand considerably with the absorption of wound exudate. - Not for use on dry wounds. In addition the following patients shall excluded from this study: - Patients unable to understand the use of the VAS tool. - Pregnant or lactating women - Patients participating in another clinical trial at the time of inclusion - Patient not covered by health insurance/social security - Patients not able to give written Informed Consent - Patients not legally capable
Addresses
Primary Sponsor
- Address:
- Lohmann & Rauscher GmbH & Co.KGDr. Martin AbelIrlicher Str. 5556567 NeuwiesGermany
- Telephone:
- 0049 2631 99 6566
- Fax:
- 0049 2631 99 1566
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Helios-KliniumDr. med. Peter LübkeColditzer Strasse 4804703 LeisnigGermany
- Telephone:
- +49 34321 8 - 2505
- Fax:
- +49 34321 8 - 2444
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.helios-gesundheit.de/leisnig
Contact for Public Queries
- Address:
- Helios-KliniumDr. med. Peter LübkeColditzer Strasse 4804703 LeisnigGermany
- Telephone:
- +49 34321 8 - 2505
- Fax:
- +49 34321 8 - 2444
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.helios-gesundheit.de/leisnig
Principal Investigator
- Address:
- Helios-KliniumDr. med. Peter LübkeColditzer Strasse 4804703 LeisnigGermany
- Telephone:
- +49 34321 8 - 2505
- Fax:
- +49 34321 8 - 2444
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.helios-gesundheit.de/leisnig
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Lohmann & Rauscher GmbH & Co.KGIrlicher Str. 5556567 NeuwiesGermany
- Telephone:
- 0049 2631 99 6566
- Fax:
- 0049 2631 99 1566
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Sächsische Landesärztekammer EthikkommissionSchützenhöhe 1601099 DresdenGermany
- Telephone:
- +49-351-8267333
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-09-09
- Ethics committee number:
- EK-BR-111/22-1
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-12-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry