Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2022-12-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A post market clinical follow-up study investigating the safety of Biatain Silicone Sacral while used as prevention in hospital admitted patients at risk of developing a pressure injury.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer

NCT03442777

Pressure Ulcer

COMPLETED NA

Clinical Trial of the WC360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures

NCT03234894

Bleeding

UNKNOWN NA

A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts

NCT02476318

Vascular Disease

COMPLETED NA

Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

NCT04633291

Catheter Site Pain Catheter Site Discomfort

COMPLETED NA

Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

NCT03823963

Pressure Ulcers Prevention Skin Ulcer +1 more

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigation was a multi-centre, open label, non-comparative, single-arm, prospective study, conducted at three investigational sites in Danish hospitals. 67 hospital-admitted patients were enrolled in the study over a 3-month recruitment period. The target population were patients ≥18 years of age with an expected hospital-stay of more than 24 hours from baseline and a Braden score of 6-18.

At daily visits skin inspections for signs of non-blanchable erythema or sacral pressure injury were performed by partial lift and reapplication of the dressing. After 7 days, or earlier if the patient was discharged, a termination visit was performed. Skin assessment was performed upon removal of the dressing and a termination form completed. Information regarding adverse events and device deficiencies were collected at all visits.

There were no follow-up visits after termination of the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Injury Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-labelled, non-comparative, single-arm, prospective, multi-center investigation.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biatain Silicone Sacral Dressing

Group Type EXPERIMENTAL

Biatain Silicone Sacral dressing

Intervention Type DEVICE

Biatain Silicone Sacral dressing will be applied over the bony prominence of the sacral area as part of a PIP (Pressure Injury Prevention) protocol in patients at risk

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biatain Silicone Sacral dressing

Biatain Silicone Sacral dressing will be applied over the bony prominence of the sacral area as part of a PIP (Pressure Injury Prevention) protocol in patients at risk

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Hospital-admitted patients at risk of developing a pressure injury with an expected hospital-stay of more than 24 hours from visit 1
* ≥18 years of age and has full legal capacity
* Has given written consent to participate by signing the Informed Consent signature Form
* Has a Braden score of 6-18 at screening (performed within the last 24 hours)
* Intact sacral skin (non-breached skin, without signs of non-blanchable erythema over bony prominence/pre-existing sacral pressure injury over bony prominence)

Exclusion Criteria

* Suspected or actual spinal injury precluding the patient from being turned
* Sacral erythema, sacral pressure marks, pre-existing sacral pressure injury
* Trauma to sacrum
* Topical treatment with steroid creme in the sacral area (treatment must have been terminated at least 14 days prior to enrollment)
* Pregnancy or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No