NCT04311229

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

February 28, 2020

Last Update Submit

March 13, 2020

Conditions

Pressure Ulcers Stage IIIPressure Ulcer, Stage IV

Keywords

Negative-Pressure Wound TherapyPressure injuriesvacuum assisted closurewound careWound Measurement

Outcome Measures

Primary Outcomes (2)

  • Granulation tissue formation and wound shrinkage

    Granulation tissue formation (%) and wound shrinkage (cm²) in experimental and control groups

    8 week

  • PUSH tool and 3-DWM measurement findings

    Wound area assessed by PUSH tool and wound area and granulation tissue assessed by 3-DWM device

    8 week

Study Arms (2)

Negative-Pressure Wound Therapy group

EXPERIMENTAL

NPWT was applied three times for Class III and pressure ulcers. An initial pre-treatment measurement was used as a baseline, followed by three post-treatment measurements after each round to evaluate wound healing. A total of four measurements were performed for each subject. Wound healing was measured using the PUSH Tool and the 3DWM device in both groups.

Device: Negative-Pressure Wound Therapy group

CONTROL GROUP

OTHER

wet to dry dressing group

Other: contol group

Interventions

Negative-Pressure Wound Therapy groupDEVICE

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.

Negative-Pressure Wound Therapy group
contol groupOTHER

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.

CONTROL GROUP

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having class III or IV pressure ulcer
  • being ≥18 years old,
  • not having time/access constraints,
  • voluntariness.

You may not qualify if:

  • Stage I and Stage II pressure ulcers,
  • cancer,
  • increased risk of bleeding,
  • osteomyelitis,
  • corticosteroid treatment
  • consciousness and
  • contraindications of NPWT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Ersilia LA, Anagha K, Thomas EB, KAthryn MM, John SS, Karen KE, Paul JK, Christopher EA, Reliability of a novel 3D Wound Measurement Device, 2015

    BACKGROUND

  • Bills JD, Berriman SJ, Noble DL, Lavery LA, Davis KE. Pilot study to evaluate a novel three-dimensional wound measurement device. Int Wound J. 2016 Dec;13(6):1372-1377. doi: 10.1111/iwj.12534. Epub 2015 Nov 11.

    PMID: 26558349BACKGROUND

  • Moues CM, van den Bemd GJ, Heule F, Hovius SE. Comparing conventional gauze therapy to vacuum-assisted closure wound therapy: a prospective randomised trial. J Plast Reconstr Aesthet Surg. 2007;60(6):672-81. doi: 10.1016/j.bjps.2006.01.041. Epub 2006 Jun 22.

    PMID: 17485058BACKGROUND

  • Sinha K, Chauhan VD, Maheshwari R, Chauhan N, Rajan M, Agrawal A. Vacuum Assisted Closure Therapy versus Standard Wound Therapy for Open Musculoskeletal Injuries. Adv Orthop. 2013;2013:245940. doi: 10.1155/2013/245940. Epub 2013 Jun 26.

    PMID: 23878741BACKGROUND

Related Links

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • EZGİ ARAYAN, Msc

    BAŞKENT ÜNİVERSİTESİ İSTANBUL SAĞLIK UYGULAMA VE RAŞTIRMA MERKEZİ

    PRINCIPAL INVESTIGATOR

  • SELDA RIZALAR, Assoc.Prof.

    İSTANBUL MEDİPOL ÜNİVERSİTESİ

    STUDY DIRECTOR

  • EMRE ÖZKER, Assoc.Prof.

    BAŞKENT ÜNİVERSİTESİ İSTANBUL SAĞLIK UYGULAMA VE RAŞTIRMA MERKEZİ

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: REPEATIVE MEASUREMENT EXPERİMENTAL AND CONTROL GROUPS
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 17, 2020

Study Start

October 13, 2016

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

March 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

to publish the article

Shared Documents
STUDY PROTOCOL
Time Frame
2020
Access Criteria
all academician and practicioners