NCT04311229

Effectiveness of Negative-Pressure Wound Therapy

Completed NA Last updated 17 March 2020

What this trial tests

NA trial testing Negative-Pressure Wound Therapy group in Pressure Ulcers Stage III in 30 participants. Completed in 30 April 2017.

Timeline

13 October 2016

Primary endpoint
30 April 2017

30 April 2017

Quick facts

Lead sponsor	Istanbul Medipol University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	13 October 2016
Primary completion	30 April 2017
Estimated completion	30 April 2017

Drugs / interventions tested

• Negative-Pressure Wound Therapy group
• contol group

Conditions studied

• Pressure Ulcers Stage III — all drugs for Pressure Ulcers Stage III →
• Pressure Ulcer, Stage IV — all drugs for Pressure Ulcer, Stage IV →

Sponsor

Istanbul Medipol University Hospital

Who can join

Adults 18 to 79, any sex, with Pressure Ulcers Stage III or Pressure Ulcer, Stage IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to compare the effects of Negative-Pressure Wound Therapy and wet-to-dry dressing on Stages 3 and 4 pressure injuries, and to investigate the consistency of Three-Dimensional Wound Measurement Device findings with Pressure Ulcer Scale for Healing Tool scores. This study is a randomized controlled trial. A total of 30 patients with Stages 3 and 4 pressure injuries were included in the study. The patients were divided into two groups: the experimental group or Negative-Pressure Wound Therapy group and the control or wet-to-dry dressing group. All patients received 3 rounds of treatment. Data were collected with a Patient Identification Form, Pressure Ulcer Scale for Healing Tool and the findings of Three-Dimensional Wound Measurement Device. We found that granulation tissue formation was more significant in the experimental group (p \< .05), and that there was more significant wound shrinkage (p \< .05) with a more significant decrease in the Pressure Ulcer Scale for Healing Tool scores (p \< .05). The wounds were assessed with the Tool and the Three-Dimensional Wound Measurement device. Device measurements were found to be correlated with Pressure Ulcer Scale for Healing Tool Tool findings (p \< .05) There was a significant correlation between device-measured granulation findings and PUSH Tool score results of the experimental group's third measurements (p \< .05). We conclude that Negative-Pressure Wound Therapy is an effective treatment method for pressure injuries, and Three-Dimensional Wound Measurement device is an usable wound assessment tool.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Negative pressure wound therapy for treating pressure ulcers.
   Shi J, Gao Y, Tian J, Li J, et al · · 2023 · cited 10× · PMID 37232410 · DOI 10.1002/14651858.cd011334.pub3