A Randomised Clinical Trial of the Negative Pressure Wound Therapy Versus Conventional Dressing for Pressure Ulcers Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 40
- Primary Endpoint
- ulcer size
Study Overview
Brief Summary
This study will compare the NPWT using the NPD to the conventional wound dressing and specifically evaluating (i) reduction of wound surface area and depth, (ii) removal of slough and formation of granulation tissue
Detailed Description
Initial debridement of slough and necrotic tissue was performed in all patients at the time of admission and before their being allocated in a group.
it's 3 groups:
Group (A): conventional dressing :
acting by:preventing pus, the findings from the review indicate that decreasing frictional forces transmitted to the patient's skin is achieved by use of a dressing with an outer surface made from a low friction material.
The surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound. Dressing changes will be performed once or twice daily depending on the soakage of the dressing.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Based on determining the main outcome variable, the estimated minimum required sample size is 39 patients (13 patient in each group
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stages three and four PU as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
Exclusion Criteria
- •wound with necrotic tissue unlikely to tolerate debridement. Exposed Vessels, Nerves and or organs. Active bleeding. Ischemic limb. Opening into body cavity
Outcomes
Primary Outcomes
ulcer size
Time Frame: 3 weeks
measured for its greatest length ,depth and width with flexigrid Opsite.
Secondary Outcomes
No secondary outcomes reported
Investigators
issraa Aly
resident doctor
Assiut University