Status:
COMPLETED
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Acute Non Infected Wounds
Non Infected Post Surgical Wounds
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Acute non infected wound or infected post surgical wound suitable for Negative Pressure Wound Therapy according to the investigator's judgment
- 3 cm2 ≤ Wound size ≤ 300 cm2
- Male or female ≥18 years
- Signed Informed Consent Form
Exclusion
- Need for frequent dressing changes, i.e.\<48 hours between the changes
- Dry wounds
- Malignancy in the wound and/or wound margin
- Untreated osteomyelitis
- Untreated infection waiting for other intervention
- Unexplored fistulas
- \> 10% necrotic tissue with eschar present after debridement
- High risk for bleeding complications (including subject treated with anticoagulants that are associated with 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
- Pregnancy
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
- Target ulcer previously not successfully treated with NPWT within 48 hours from NPWT start
- Subject unable to understand written patient information due to medical condition
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01195896
Start Date
September 1 2010
End Date
September 1 2011
Last Update
January 16 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ulm University Hospital
Ulm, Germany