An Evaluation of the Impact of a Wound Dressing on Pressure Ulcer Incidence.

NCT03894267 | Unknown

• 1 other identifier: NM/1002/2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A pressure ulcer (PU) is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear. PUs are common, affecting up to 40% of participants receiving health care. Furthermore, PUs impact negatively on an individual's health related quality of life, with pain being the most frequently cited complaint. PUs commonly occur in those who cannot reposition themselves to relieve pressure/shear over bony prominences. The ability to reposition is often diminished in the very old, the malnourished and those with acute illness. Pressure ulcers are common devastating wounds, extending from deep in the bone and muscle layers through to the skin, occurring most often in older persons with limited mobility. They contribute to significant morbidity and mortality as they are smelly, highly painful and very prone to infection. Existing research carried out by the RCSI School of Nursing and Midwifery shows that both high and low movers are at risk of pressure ulcer development.

Conditions

Wounds

Outcome Measures

Primary Outcomes (1)

• Pressure Ulcer incidence

  The primary objective is to examine the pressure ulcer occurrence in the two participant groups.

  12 months

Secondary Outcomes (1)

• PU incidence related to movement.

  12 months

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Self-adhesive silicone bordered foam dressing will be secured to the heels and sacrum. Daily SEM reading, visual skin assessment. Early Sense placed under study subject's mattress. Follow up 20 days

Device: Cutimed Siltec Heel and Sacrum dressing

Control Arm

NO INTERVENTION

Daily SEM reading, visual skin assessment. Early Sense placed under study subject's mattress. Follow up for 20 days.

Interventions

Cutimed Siltec Heel and Sacrum dressing DEVICE

The dressing has been developed to facilitate exudate management in the treatment of wounds. Newly formed tissue enjoys optimal protection under a moist environment. The foam core with super-absorbers ensures reliable absorption in slightly to heavily exuding wounds. This core has an excellent retention capacity, even under compression. Hydrogen bridges bind the water so securely that, even when subject to pressure, the water is not released. Vertical absorption through the polyurethane foam and the hydro- phobic wound contact layer minimizes the risk of macerations in the peri-ulcer skin.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be considered eligible if they fulfil the following criteria:
• male or female subject aged at least 18 years
• willing and able to give written informed consent and to comply with the requirements
• being at risk of PU development as measured by the activity and mobility components of a mobility assessment tool

You may not qualify if:

• Participants will be ineligible for enrolment if they meet any of the following criteria:
• unable to provide written informed consent
• known hypersensitivity to any of the ingredients
• participant in any clinical trial of an investigational medicinal product (CTIMP or clinical investigation within 30 days prior to screening)

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Cherry Orchard Hospital

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Zena Moore, PhD

  RCSI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Declan Patton, PhD

CONTACT

35314022184; declanpatton@rcsi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, randomized control design.

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: March 28, 2019
• Study Start: March 12, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 28, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)