- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06243328
Effect of Negative Wound Pressure on P.S
A Randomised Clinical Trial of the Negative Pressure Wound Therapy Versus Conventional Dressing for Pressure Ulcers Management
Study Overview
Status
Conditions
Intervention / Treatment
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.
.
Group (B), negative pressure wound therapy using the electronic-vac :
It is believed that the negative pressure assists in removal of interstitial fluid, decreasing oedema, increasing blood flow and reducing tissue bacterial levels, in addition, mechanical deformation of cells is thought to result in protein and matrix molecule synthesis, which increases the rate of cell proliferation and granulation tissue formation, this , in turn , may promote healing .
We will place a nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape. The dressing will be connected to the machine through tubing that was connected to the canister. Continuous pressure of 200 mm Hg will be applied. The dressing will be changed three times a week Group (C), negative pressure wound therapy using the Romo-vac: The NPD will be applied as a bedside procedure with a low-power continuous suction apparatus. We will Place nonadherent contact layer, such as Xeroform between prepared wound bed and contact dressing with sealling using an adhesive drape. The dressing will be connected to the Romo-vac which applying pressure of-60 to -125 mm Hg. The Romo-vac will be recharged every 5-6 hours and the dressing will be changed three times a week or earlier if there is a soakage/leakage
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: issraa aly mohamed, resident doctor
- Phone Number: 01097426746
- Email: issraaaly96@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: conventional dressing
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
|
nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape.
The dressing will be connected to the machine through tubing that was connected to the canister
|
Experimental: negative pressure wound therapy
We will place a nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape.
The dressing will be connected to the machine through tubing that was connected to the canister.
Continuous pressure of 200 mm Hg will be applied.
The dressing will be changed three times a week.
|
nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape.
The dressing will be connected to the machine through tubing that was connected to the canister
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ulcer size
Time Frame: 3 weeks
|
measured for its greatest length ,depth and width with flexigrid Opsite.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: assem hussien, professor, Assiut University
Publications and helpful links
General Publications
- Avsar P, Moore Z, Patton D. Dressings for preventing pressure ulcers: how do they work? J Wound Care. 2021 Jan 2;30(1):33-39. doi: 10.12968/jowc.2021.30.1.33.
- Srivastava RN, Dwivedi MK, Bhagat AK, Raj S, Agarwal R, Chandra A. A non-randomised, controlled clinical trial of an innovative device for negative pressure wound therapy of pressure ulcers in traumatic paraplegia patients. Int Wound J. 2016 Jun;13(3):343-8. doi: 10.1111/iwj.12309. Epub 2014 Jun 3.
- Lesiak AC, Shafritz AB. Negative-pressure wound therapy. J Hand Surg Am. 2013 Sep;38(9):1828-32. doi: 10.1016/j.jhsa.2013.04.029. Epub 2013 Jun 25. No abstract available.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAC on PS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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