Effect of Negative Wound Pressure on P.S

NCT ID: NCT06243328

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2024-12-31

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.

.

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

Conditions

Pressure Sores

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

negative wound pressure therapy

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

negative wound pressure therapy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

issraa Aly

resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

assem hussien, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

issraa aly mohamed, resident doctor

Role: CONTACT

issraaaly96@gmail.com

01097426746

References

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.

Reference Type: BACKGROUND

PMID: 33439083 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24894079 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23809469 (View on PubMed)

Other Identifiers

VAC on PS

Identifier Type: -

Identifier Source: org_study_id