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ClinicalTrials.gov ID

NCT07316556

Lead Sponsor

Lohmann & RauscherINDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

208Estimated

Last Update Posted

Jan 5, 2026Actual

Start Date

Mar 11, 2024Actual

Primary Completion Date

Jan 31, 2027Estimated

Completion Date

Jan 31, 2027Estimated

Official Title

Prospective Systematic Data Collection for Post-Marketing Surveillance of Vliwazell® Pro Wound Dressing

Brief Summary

This PMCF study is conducted to confirm the effectiveness and safety of the wound dressing Vliwazell® Pro. The aim of the study is to validate the performance of Vliwazell® Pro within its intended purpose and certified indications during routine use, and to gather additional safety data. The study will examine how the use of the dressing affects the condition of the skin surrounding the wound, the wound status in terms of exudate, wound odor, and other parameters. Furthermore, the satisfaction of healthcare providers and patients with the application of the dressing will be assessed.

Detailed Description

Vliwazell® Pro is a flexible and soft superabsorbent wound dressing designed for acute and chronic wounds with moderate to very high levels of exudate (wound fluid). The inner non-woven layer helps evenly distribute the exudate and rapidly channel it into the absorbent core. Excess wound fluid is retained in this layer, protecting the wound and surrounding tissue from maceration.

Vliwazell® Pro has high absorbent capacity and reduces the need for frequent dressing changes due to saturation, allowing the wound to remain undisturbed for longer periods. The outer layer is covered with a blue non-woven fabric that shields the patient's clothing and bed linen.

• Acute and Chronic Wounds

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

Wound according to indication mentioned in the instructions for use:

1. Superficial acute and chronic wounds with moderate to very high amounts of exudate and that are superficial, in:

   • arterial and venous ulcers
   • diabetic ulcers
   • pressure ulcers
   • post-traumatic wounds
   • post-operative wounds healing by secondary intention
   • skin graft donor sites
   • oncological wounds
   • ulcerating tumors
   • wounds at risk of infection
   • superficial 2nd degree burns
   • lymphatic wounds

2. As secondary dressing on laparotomy wounds and fistulas or for deep wounds when used with appropriate wound filler

3. Patient has full legal capacity

4. Patient is able to understand and provide information

5. Patient has signed the written Informed Consent Form

Exclusion Criteria:

1. Age < 18 years

2. Patient with contraindication:

   • Known allergy and/or hypersensitivity to any of the product 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.

3. Pregnant or lactating women

4. Patients participating in another clinical trial at the time of inclusion

5. Patient not covered by health insurance/social security

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

Lohmann & RauscherINDUSTRY

info@brueggen.mvzsn.de+49 2163 5749 100

info@orgamed-dortmund.de+ 49 231 - 936970

hautklinik@uk-erlangen.de+49 9131 85-35000