Effect of Negative Wound Pressure on P.S

January 29, 2024 updated by: issraa Aly, Assiut University

A Randomised Clinical Trial of the Negative Pressure Wound Therapy Versus Conventional Dressing for Pressure Ulcers Management

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

Study Overview

Status

Not yet recruiting

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

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: negative wound pressure therapy
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.
Device: negative wound pressure therapy
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

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: assem hussien, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

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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