Acute and Chronic Wounds
Conditions
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.
Interventions
DEVICEExternal 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.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Sweden
Outcome results
None listed