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
The investigation is designed as a prospective, open, non-controlled clinical investigation.
Acute Non Infected Wounds
Non Infected Post Surgical Wounds
Device: New NPWT system
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Granulation tissue formation [ Time Frame: maximum 3 weeks ] [ Designated as safety issue: No ]To assess the wound healing and granulation tissue formation when using the NPWT system
- Handling of NPWT system [ Time Frame: maximum 3 weeks ] [ Designated as safety issue: No ]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
|Study Start Date:||September 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Device: New NPWT system
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.