Clinical trial NCT04311229: Effectiveness of Negative-Pressure Wound Therapy
Official title: Effectiveness of Negative-Pressure Wound Therapy Compared to Wet-Dry Dressing in Pressure Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers Stage III
Pressure Ulcer, Stage IV
Keywords: Negative-Pressure Wound Therapy
Pressure injuries
vacuum assisted closure
wound care
Wound Measurement
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 30
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: REPEATIVE MEASUREMENT EXPERİMENTAL AND CONTROL GROUPS
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Granulation tissue formation and wound shrinkage
timeFrame: 8 week
measure: PUSH tool and 3-DWM measurement findings
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: BAŞKENT ÜNİVERSİTESİ İSTANBUL SAĞLIK UYGULAMA VE RAŞTIRMA MERKEZİ
name: EZGİ ARAYAN, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: İSTANBUL MEDİPOL ÜNİVERSİTESİ
name: SELDA RIZALAR, Assoc.Prof.
role: STUDY_DIRECTOR
affiliation: BAŞKENT ÜNİVERSİTESİ İSTANBUL SAĞLIK UYGULAMA VE RAŞTIRMA MERKEZİ
name: EMRE ÖZKER, Assoc.Prof.
role: STUDY_DIRECTOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.