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

NCT05619003 | Completed Results

• 1 other identifier: CP346
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pressure Injury Prevention

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Evaluate the safety of Biatain Silicone Sacral. Adverse events considered related to the investigational device by the investigator during the investigation period (up to 7 days or until discharged)

  7 days

Secondary Outcomes (1)

• Number of Device Deficiencies

  7 days

Study Arms (1)

Biatain Silicone Sacral Dressing

EXPERIMENTAL

Device: Biatain Silicone Sacral dressing

Interventions

Biatain Silicone Sacral dressing 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

Biatain Silicone Sacral Dressing

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (3)

Bispebjerg Hospital

Copenhagen, Denmark

Location

Herlev Hospital

Copenhagen, Denmark

Location

Hvidovre Hospital

Copenhagen, Denmark

Location

Results Point of Contact

• Title: Senior Scientific Manager
• Organization: Coloplast

dkcpov@coloplast.com

+45 49112880

Study Officials

• Christina Overgaard, SSM

  Coloplast A/S

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

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

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 16, 2022
• Study Start: August 15, 2022
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)