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Pressure Ulcers Stage IIINCT04311229

Effectiveness of Negative-Pressure Wound Therapy

A study testing Negative-Pressure Wound Therapy group and contol group in people with Pressure Ulcers Stage III and Pressure Ulcer, Stage IV, run by Istanbul Medipol University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
What is being tested?
Negative-Pressure Wound Therapy group and contol group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
13 Oct 2016to 30 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Effectiveness of Negative-Pressure Wound Therapy Compared to Wet-Dry Dressing in Pressure Injuries

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.

Read the detailed description

Pressure injuries are a major health problem in that they are difficult to treat, reduce the patients' quality of life, and increase length of hospital stay and overall health care costs. Furthermore, several possible wound healing complications, such as infections, can lead to mortality. That said, the prevalence of pressure injuries is an important indicator of quality in hospitals. Pressure injuries do not only impact health, but also cause social isolation and dependency, resulting in further psychological problems.

Our review of the literature revealed that the incidence of pressure ulcers varies between 0.4% and 38% in hospitalized patients, between 2.2 and 23.9% in intensive care units and between 0-17% in home care. NPUAP (National Pressure Ulcer Advisory Panel) reports that the cost of treating pressure ulcers has been gradually increasing. It was estimated that treating pressure injuries costs around $11 billion annually in the United States alone. Treating a pressure ulcer can cost anywhere between $500 to $70,000, the most substantial fraction being nursing services. In the UK, it costs £1,064 to treat a Stage 1 pressure injury, and this number can reach £10,551 for more advanced ulcers. This illustrates the direct link between the stage of pressure injury and the cost of treatment. On average, it costs the UK healthcare system £1.4-2.1 billion annually to treat pressure ulcers.

There are many products and methods available for pressure ulcer treatment, but the most well-known and most commonly preferred method is wet-to-dry dressing. That said, researchers have tried and developed several novel methods for the treatment of pressure injuries including NPWT (Negative-Pressure Wound Therapy), hyperbaric oxygen therapy, ultrasonography, hydrotherapy, magnetic field therapy, ultraviolet rays, electrical stimulation, phototherapy and growth hormone application. Together with these non-invasive treatment methods, surgical intervention can also be a treatment option, especially for non-healing wounds. The European and US National Pressure Ulcer Advisory Panels' (EPUAP and NPUAP) guidelines recommend NPWT for deep-tissue pressure injuries, namely Stages 3 and 4, as a supportive tool for early-stage treatment. This method is based on applying negative pressure to promote wound healing. Several studies report that NPWT increases granulation tissue formation and reduces wound area. It is indicated that NPWT provides continuous and effective wound debridement in the wound area and increases blood supply to the wound.

Pressure injuries are among the most significant current health problems that are handled by a medical nurse. As the primary caregiver for the hospitalized patient, the nurse must prioritize preventing wound formation and eliminating any risk factors. If a pressure sore does form, the primary goal is to plan and implement appropriate care and nursing interventions in collaboration with the patient and their family to ensure proper wound healing .

It is the nurse's responsibility to keep up with scientific developments in patient care and try to integrate them into their work. PUSH is a tool that is used for monitoring pressure ulcers; however, it has yet to become a part of routine practice in Turkey. The Three-Dimensional Wound Management (3-DWM) device has been used in medical service since 2015, but with only a limited number of studies that evaluate its effectiveness. Currently, the wet-to-dry dressing method is the most commonly preferred treatment method for wound care in Turkish healthcare. There are indeed numerous studies that demonstrate the effectiveness of wet dressings in wound healing. Wet dressings provide the appropriate medium for the accumulation of patient's own body fluids between wound surface and dressing while preventing dehydration. This study aims to compare the effects of Negative-Pressure Wound Therapy (NPWT) and wet-to-dry dressing on Stages 3 and 4 pressure injuries, and to investigate the consistency of 3-DWM device measurement findings with PUSH Tool scores.

Being tested
Negative-Pressure Wound Therapy group, contol group
Keywords
Negative-Pressure Wound Therapy, Pressure injuries, vacuum assisted closure, wound care, Wound Measurement
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT04311229
Study groupRoleWhat they receive
Negative-Pressure Wound Therapy groupExperimentalNPWT 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.
Receives: Device: Negative-Pressure Wound Therapy group
CONTROL GROUPOtherwet to dry dressing group
Receives: Other: contol group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Granulation tissue formation and wound shrinkage

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

    Measured: 8 week

  2. PUSH tool and 3-DWM measurement findings

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

    Measured: 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2020
  2. Study start13 Oct 2016
  3. Primary completion30 Apr 2017
  4. Study completion30 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
REPEATIVE MEASUREMENT EXPERİMENTAL AND CONTROL GROUPS
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04311229
Sponsor's protocol ID
20052020
Status last verified
Feb 2020
First submitted
28 Feb 2020
Last updated
17 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: to publish the article

Publications

  • 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

  • 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.

    PubMed 26558349
  • 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.

    PubMed 17485058
  • 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.

    PubMed 23878741

Questions about this trial

What is this clinical trial studying?

A study testing Negative-Pressure Wound Therapy group and contol group in people with Pressure Ulcers Stage III and Pressure Ulcer, Stage IV, run by Istanbul Medipol University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Granulation tissue formation and wound shrinkage (time frame: 8 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04311229, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.

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