Effect of Negative Wound Pressure on P.S

Pressure Sores Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06243328
• Other study ID #: VAC on PS
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: issraa aly mohamed, resident doctor
• Phone: 01097426746
• Email: issraaaly96[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Sores
• Pressure Ulcer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ulcer size	measured for its greatest length ,depth and width with flexigrid Opsite.	3 weeks