Effect of Negative Wound Pressure on P.S

NCT06243328 | Unknown

• 1 other identifier: VAC on PS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pressure Sores

Outcome Measures

Primary Outcomes (1)

• ulcer size

  measured for its greatest length ,depth and width with flexigrid Opsite.

  3 weeks

Study Arms (2)

conventional dressing

EXPERIMENTAL

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

negative pressure wound therapy

EXPERIMENTAL

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

Interventions

negative wound pressure therapy 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

conventional dressing; negative pressure wound therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stages three and four PU as defined by the National Pressure Ulcer Advisory Panel (NPUAP).

You may not qualify if:

• wound with necrotic tissue unlikely to tolerate debridement. Exposed Vessels, Nerves and or organs. Active bleeding. Ischemic limb. Opening into body cavity

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 33439083 BACKGROUND

• 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.

  PMID: 24894079 BACKGROUND

• 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.

  PMID: 23809469 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• assem hussien, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

issraa aly mohamed, resident doctor

CONTACT

01097426746; issraaaly96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Based on determining the main outcome variable, the estimated minimum required sample size is 39 patients (13 patient in each group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-01