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The Effect of Multilayer Silicone Foam compared to Transparent Film in Pressure Injury Prevention on Heels Due to the Surgical Position

Effectiveness of Multilayer Silicone Foam compared to Transparent Polyurethane Film in Pressure Injury Prevention on Heels Due to Surgical Positioning: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5gkng5
Enrollment
Unknown
Registered
2017-10-25
Start date
2019-03-18
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

pressure ulcer

Interventions

Experimental group: 152 heels will receive multilateral soft silicone foam dressing. Control group: 152 heels will receive transparent polyurethane film dressing. Totalizing 304 heels (152 patients on
Other
E07.101

Sponsors

Universidade Federal de Santa Maria - UFSM
Lead Sponsor
Universidade Federal de Santa Maria - UFSM
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients hospitalized at the Hospital Universitário de Santa Maria during the preoperative period of elective surgery of digestive or cardiac specialty; age equal to or greater than 18 years; evaluated for follow-up at least 12 hours before the surgical procedure by the researcher or research assistants; with the heels pair intact until the second evaluation (preoperative in the surgical center)

Exclusion criteria

Exclusion criteria: American Society of Anesthesiologists score = VI; pregnant or suspected pregnancy; with impaired verbal communication without an accompanying person, or altered level of consciousness without an accompanying person; lower limb amputation; fracture in one of the lower limbs in use of skeletal traction or external fixator, plaster, dressing that forbid access to heels; surgical procedure performed exclusively in the prone position

Design outcomes

Primary

MeasureTime frame
Decrease on pressure ulcer incidence between intervention and control group during 3 postoperative days, identifyed by National Pressure Ulcer Advisory Panel classification, that will be statistically significant. Evaluations will be made daily.—

Secondary

MeasureTime frame
Skin temperature increase during 3 postoperative days verified by infrared thermographer from observation of at least 1ºC in the pre and post-intervention measurements. Skin moisture increase during 3 postoperative days verified by capacitance from observation of at least 5 AU in the pre and post-intervention measurements.—

Countries

Brazil

Contacts

Public ContactThaís Eberhardt

Universidade Federal de Santa Maria - UFSM

thaiseberhardt@gmail.com55811458789

Outcome results

None listed

Source: REBEC (via WHO ICTRP)