Faster wound healing with topical negative pressure therapy in difficult to heal wounds
Completed
- Conditions
- Difficult to heal wounds of various aetiologiesInjury, Occupational Diseases, PoisoningOpen wounds involving multiple body regions
- Registration Number
- ISRCTN36051617
- Lead Sponsor
- Radboud University Nijmegen Medical Centre (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
1. Aged greater than or equal to 18 years, either sex
2. Difficult to heal surgical wounds (i.e. dehisced abdominal wounds, complex pilonidal sinus, infected wounds and pressure ulcers)
3. Paraplegic and tetraplegic patients with pressure ulcers grade IV according to the European Pressure Ulcer Advisory Panel grading system
Exclusion Criteria
1. Untreated osteomyelitis
2. A life expectation less than one year
3. Radiation or chemical exposure
4. Pregnant or lactating females
5. Not able to comply to one of the interventions
6. Treated with one of the study treatments in the past 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to 50% wound volume reduction, with a maximum follow-up time of six weeks. This point was determined by measuring the difference between the weekly measured wound volume and the initial wound volume before treatment.
- Secondary Outcome Measures
Name Time Method 1. Wound healing failure rates, defined as any deterioration of the wound that necessitated changing the treatment protocol to which patient was assigned<br>2. Any adverse event, defined as any unfavourable and unintended diagnosis, symptom, sign, syndrome, or disease that either arose during the study, or seemed to deteriorate, if present at baseline<br><br>Wound healing failure and adverse events were only diagnosed as such after confirmation by an independent physician.