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Pilot Study: Evaluation of a silicone gel adhesive hydrocellular foam dressing for the prevention of sacral pressure injuries in hospitalised elderly patients

Evaluation of a silicone gel adhesive hydrocellular foam dressing in comparison to standard care for the use in sacral pressure injuries in hospitalised elderly patients'

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000317594
Enrollment
132
Registered
2015-04-08
Start date
2015-06-16
Completion date
2017-12-07
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to gather information about the effectiveness of a foam dressing to prevent the development of sacral pressure injuries (PI). Currently, preventative dressings are not used routinely. In this study,of adult patients who are at high risk of developing a PI, half of the sample of 126 patients will be randomly allocated to receive the sacral foam dressing and half will receive standard care i.e. no sacral dressing. The dressing will remain in place for the duration of each participant's hospital stay. It will be replaced routinely after 7 days, or before if needed. In all patients, the sacral skin will be inspected on a daily basis to observe for the presence of PI, for a maximum period of 4 weeks. The main outcome measure will be the occurrence of sacral PI. Dressing comfort will be evaluated from the patient's perspective, and its utility will be evaluated by nurses. A cost analysis will also be undertaken. It is anticipated that patients treated with the foam dressing will have a lower incidence of pressure injuries than those receiving standard care.

Interventions

Intervention group patients will have the Allevyn Life Sacrum foam dressing applied to their sacrum for a maximum of 4 weeks. These dressings will be lifted and the skin beneath inspected daily by nursing staff, then the same dressing will be reapplied, unless the integrity of the dressing is compromised in which case it will be replaced. A new dressing will be applied in all cases, after 7 days in situ. Dressing changes will be monitored daily and recorded on a standardised data collection for

Intervention group patients will have the Allevyn Life Sacrum foam dressing applied to their sacrum for a maximum of 4 weeks. These dressings will be lifted and the skin beneath inspected daily by nursing staff, then the same dressing will be reapplied, unless the integrity of the dressing is compromised in which case it will be replaced. A new dressing will be applied in all cases, after 7 days in situ. Dressing changes will be monitored daily and recorded on a standardised data collection form.

Sponsors

Nursing Research and Practice Development centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) >/= 65 years of age. 2) Patients assessed to be at risk of pressure injury development i.e. Waterlow Score > 10.

Exclusion criteria

1) Pre-existing sacral pressure injury. 2) Evidence of incontinence associated dermatitis (IAD). 3) Skin disease or trauma/skin damage to sacral region. 4) Documented allergy to adhesives. 5) Patients previously recruited to the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026