Effectiveness of Negative-Pressure Wound Therapy
NCT04311229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2020-03-17
Summary
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.
Conditions
- Pressure Ulcers Stage III
- Pressure Ulcer, Stage IV
Interventions
- DEVICE
-
Negative-Pressure Wound Therapy group
The wounds were initially evaluated for any necrotic findings and debrided if needed, and then washed with an antiseptic solution. 3-DWM was used to measure the pressure sores by taking pictures.The length and width of wounds were measured with disposable paper rulers. Wound depth was determined in centimeters with a sterile cotton-tip applicator by measuring against a ruler. The wound was closed using a Wound Care Kit that includes foam dressing, film drape, TRAC pad with tubing and a drainage canister. Foam material was placed inside the wound and was attached to the canister through tubing.The canister was attached to the Vacuum-Assisted Closure device, which is a portable device that applies intermittent or continuous negative pressure.The device was operated at 125 mmHg pressure for 5 minutes with and 2 minutes without active vacuum.Wound dressings were changed every 48 hours.Wound area was measured after all three rounds of treatment.
- OTHER
-
contol group
Wounds were finally covered with gauze dressing soaked with saline. Wounds were treated three times a day, and measurements were repeated every 48 hours. Every wound was measured a total of four times: one pre-treatment (baseline) and three post-treatment measurements.
Sponsors & Collaborators
-
Istanbul Medipol University Hospital
lead OTHER
Principal Investigators
-
EZGİ ARAYAN, Msc · BAŞKENT ÜNİVERSİTESİ İSTANBUL SAĞLIK UYGULAMA VE RAŞTIRMA MERKEZİ
-
SELDA RIZALAR, Assoc.Prof. · İSTANBUL MEDİPOL ÜNİVERSİTESİ
-
EMRE ÖZKER, Assoc.Prof. · BAŞKENT ÜNİVERSİTESİ İSTANBUL SAĞLIK UYGULAMA VE RAŞTIRMA MERKEZİ
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-10-13
- Primary Completion
- 2017-04-30
- Completion
- 2017-04-30
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