Acute Non Infected Wounds, Non Infected Post Surgical Wounds
Conditions
Brief summary
The investigation is designed as a prospective, open, non-controlled clinical investigation.
Detailed description
Wounds to be treated under this protocol should be acute non-infected wounds or post surgical infected wounds in hospitalized subjects. One ulcer per subject will be treated for a maximum duration of 3 weeks. All subjects will receive continuous negative pressure treatment with the new NPWT system with a pressure level of -120 mmHg or according to clinicians' instruction based on the indication. 10-15 subjects at two sites will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and who have signed and dated a written informed consent. The subjects will be consecutively allocated to a specific subject identification code. The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation. Subject pain will be measured by using the Visual Analogue Scale, VAS. Subject and investigator convenience will be assessed by convenience surveys. Diagnosis and treatment of wound infections according to clinical routine.
Interventions
DEVICENew NPWT system
According clinical routine (Instruction for Use)
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. Acute non infected wound or infected post surgical wound suitable for Negative Pressure Wound Therapy according to the investigator's judgment 2. 3 cm2 ≤ Wound size ≤ 300 cm2 3. Male or female ≥18 years 4. Signed Informed Consent Form
Exclusion criteria
1. Need for frequent dressing changes, i.e.\<48 hours between the changes 2. Dry wounds 3. Malignancy in the wound and/or wound margin 4. Untreated osteomyelitis 5. Untreated infection waiting for other intervention 6. Unexplored fistulas 7. \> 10% necrotic tissue with eschar present after debridement 8. High risk for bleeding complications (including subject treated with anticoagulants that are associated with 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 14. Pregnancy 15. Subjects previously included in this investigation 16. Subjects included in other ongoing clinical investigation at present or during the past 30 days 17. Target ulcer previously not successfully treated with NPWT within 48 hours from NPWT start 18. Subject unable to understand written patient information due to medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Granulation tissue formation | maximum 3 weeks | To assess the wound healing and granulation tissue formation when using the NPWT system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handling of NPWT system | maximum 3 weeks | To investigate the pain level at dressing removal To visually check exudate removal To investigate the ease of use for the subject and care giver when using the NPWT system |
Countries
Germany
Outcome results
None listed