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

Phase 2

Completed

• Conditions: Acute and Chronic Wounds

• Registration Number: NCT01286857
• Lead Sponsor: Molnlycke Health Care AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-01-31
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-15
• Last Update Posted: 2011-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

County Hospital; 🇸🇪 Halmstad, Sweden

Hudmottagningen, Sundsvalls sjukhus; 🇸🇪 Sundsvall, Sweden

University Hospital of Örebro; 🇸🇪 Örebro, Sweden