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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-05-31

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.

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Detailed Description

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Conditions

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Acute and Chronic Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
2. 1cm2 ≤ wound size ≤ 200cm2
3. Male or female, 18 years and above
4. Signed Informed Consent Form
5. Subject understands the written Patient Information

Exclusion Criteria

1. Need for frequent dressing changes, i.e.\<48 hours between the changes
2. Critical ischemia (for wound healing) according to investigator's judgement
3. Malignancy in the wound and/or wound margin
4. Target ulcer previous not successfully treated with NPWT within 48 hours
5. Poorly controlled diabetes according to investigators judgement.
6. Osteomyelitis which has been left untreated
7. Infection which has been left untreated
8. High risk for bleeding complications
9. Exposed blood vessels, organs or nerves
10. Current or within 3 months treatment with chemotherapy or irradiation
11. Known hypersensitivity to the dressing material
12. Expected technically impossible to seal the film to achieve a vacuum treatment
13. Expected non compliance with the Clinical Investigation Plan (CIP)
14. Pregnancy
15. Subjects not suitable for the investigation according to the investigator's judgement
16. Subjects previously included in this investigation
17. Subjects included in other ongoing clinical investigation at present or during the past 30 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No