PIP: Pressure Injury Prevention Post-market Clinical Follow up Study, Biatain Silicone Sacral

Sponsor

Coloplast A/S (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05619003

Collaborator

(none)

Enrollment

Locations

Arm

3.4

Anticipated Duration (Months)

22.3

Patients Per Site

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective single-arm study investigating the safety of Biatain Silicone Sacral while used as prophylactic prevention amongst hospital admitted patients at risk of developing a pressure injury.

Condition or Disease	Intervention/Treatment	Phase
Pressure Injury	Device: Biatain Silicone Sacral Bandage	N/A

Detailed Description

The Biatain Silicone Sacral and Multishape dressings are multi-layer polyurethane foam dressings. They are CE-marked products and have been on the US market since April 2018. They are evaluated as safe to use and perform according to their intended purpose and indications.

This investigation is a Post-market Clinical Follow-up Study, which aims to support the clinical performance of Biatain Silicone Sacral regarding the use of the dressing as part of prophylactic therapy to help prevent skin damage, e.g. pressure injuries. A pressure injury (PI) or pres-sure ulcer (PU) is defined as localized damage to the skin and/or underlying tissue, as a result of pressure or pressure in combination with shear. PI's usually occur over a bony prominence, but may also be related to a medical device or other object.

The need for follow-up clinical data regarding this indication has been suggested in the Clinical Evaluation for Bi-atain Silicone Sacral and Multishape, and an outline of investigation CP346 is described in the Post-market Clinical Follow-up section of the Clinical Evaluation Report (CER) VV-0247441 for Biatain Silicone Sacral and Multishape.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

67 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The Clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center obser-vational investigation.The Clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center obser-vational investigation.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

PIP 1.0 - Pressure Injury Prevention Post-market Clinical Follow up Study, Biatain Silicone Sacral

Actual Study Start Date :

Aug 26, 2022

Anticipated Primary Completion Date :

Dec 8, 2022

Anticipated Study Completion Date :

Dec 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single-arm The Clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center obser-vational investigation	Device: Biatain Silicone Sacral Bandage Biatain Silicone sacral will be applied on the sacral area as prevention of Pressure Ulcers

Arm

Intervention/Treatment

Experimental: Single-arm

The Clinical investigation is an open-labelled, non-comparative, single-arm, prospective, multi-center obser-vational investigation

Device: Biatain Silicone Sacral Bandage

Biatain Silicone sacral will be applied on the sacral area as prevention of Pressure Ulcers

Outcome Measures

Primary Outcome Measures

Number of Adverse Events [25th August - 8th December 2022]
Examine the safety of Biatain Silicone Sacral

Secondary Outcome Measures

Number of Device Deficiencies [25th August - 8th December 2022]
Examine the safety of Biatain Silicone Sacral

Other Outcome Measures

Exploratory Outcome: Hospital-acquired sacral pressure injuries during investigation period (Yes/No) [25th August - 8th December 2022]
Examine the performance of Biatain Silicone Sacral, regarding its ability to help prevent pressure injuries.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country
1	Bispebjerg Hospital	Copenhagen	Denmark
2	Herlev Hospital	Copenhagen	Denmark
3	Hvidovre Hospital	Copenhagen	Denmark

Sponsors and Collaborators

Coloplast A/S

Investigators

Study Chair: Christina Overgaard, SCM, Coloplast A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Coloplast A/S

ClinicalTrials.gov Identifier:

NCT05619003

Other Study ID Numbers:

CP346

First Posted:

Nov 16, 2022

Last Update Posted:

Nov 16, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wounds and Injuries

Crush Injuries

Study Results

No Results Posted as of Nov 16, 2022