An Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds

Study Overview
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Brief Summary
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The aim of the investigation is to evaluate the function of two new device parts to be used in a NPWT system; an on-top suction device intended to transport exudate from the wound and a silicon cover film intended to fixate the wound filler and seal tight to the skin in order to keep a moist environment.

Official Title
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A Prospective, Open, Non-controlled Proof-of-concept Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds

Conditions
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Acute and Chronic Wounds

Intervention / Treatment
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* Device: External Suction Interface and a Silicon Film


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment 1cm2 ≤ wound size ≤ 200cm2 Male or female, 18 years and above Signed Informed Consent Form Subject understands the written Patient Information Exclusion Criteria: Need for frequent dressing changes, i.e.<48 hours between the changes Critical ischemia (for wound healing) according to investigator's judgement Malignancy in the wound and/or wound margin Target ulcer previous not successfully treated with NPWT within 48 hours Poorly controlled diabetes according to investigators judgement. Osteomyelitis which has been left untreated Infection which has been left untreated High risk for bleeding complications Exposed blood vessels, organs or nerves Current or within 3 months treatment with chemotherapy or irradiation Known hypersensitivity to the dressing material Expected technically impossible to seal the film to achieve a vacuum treatment Expected non compliance with the Clinical Investigation Plan (CIP) Pregnancy Subjects not suitable for the investigation according to the investigator's judgement Subjects previously included in this investigation Subjects included in other ongoing clinical investigation at present or during the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: External Suction Interface and a Silicon Film|Evaluate the function of a new silicon cover film and an on-top suction device to be used in a NPWT system in the treatment of acute and chronic wounds.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site |  | 144 - 288 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the practical properties and management of the device, to evaluate the ease of use for the subject and the care giver and to assess any undesirable effects with the suction part |  | 144-288 hours |