Trial Outcomes & Findings for Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk (NCT NCT05619003)

NCT ID: NCT05619003

Last Updated: 2025-09-10

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2025-09-10

Participant Flow

Participant milestones

Measure	Biatain Silicone Sacral Dressing Biatain Silicone Sacral will be applied over the bony prominence of the sacral area
Overall Study STARTED	67
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Biatain Silicone Sacral Dressing Biatain Silicone Sacral will be applied over the bony prominence of the sacral area
Overall Study Adverse Event	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Biatain Silicone Sacral Dressing n=66 Participants Biatain Silicone Sacral will be applied over the bony prominence of the sacral area
Age, Continuous	70.5 years n=66 Participants
Sex: Female, Male Female	39 Participants n=66 Participants
Sex: Female, Male Male	27 Participants n=66 Participants
Region of Enrollment Denmark	66 Participants n=66 Participants
BMI	27.4 kg/m2 n=66 Participants
Urinary incontinence	18 Participants n=66 Participants
Faecal incontinence	12 Participants n=66 Participants
Braden Scale Score	15.9 scores on a scale n=66 Participants

PRIMARY outcome

Timeframe: 7 days

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)

Outcome measures

Measure	Biatain Silicone Sacral Dressing n=67 Participants Biatain Silicone Sacral will be applied over the bony prominence of the sacral area
Number of Adverse Events	0 Adverse events

SECONDARY outcome

Timeframe: 7 days

Evaluate the safety of Biatain Silicone Sacral. Number of device deficiencies during the investigation period (up to 7 days or until discharged)

Outcome measures

Measure	Biatain Silicone Sacral Dressing n=67 Participants Biatain Silicone Sacral will be applied over the bony prominence of the sacral area
Number of Device Deficiencies	4 Device deficiencies

Adverse Events

Biatain Silicone Sacral Dressing

Serious events: 4 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	Biatain Silicone Sacral Dressing n=67 participants at risk 67 patients were treated with Biatain Silicone Sacral dressing over the bony prominence of the sacral area as part of a pressure injury prevention protocol
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/67 • Adverse events were collected from baseline (day 1, visit 1) and at all daily visits until termination visit (latest after 7 days). There was no follow-up after study termination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	1.5% 1/67 • Adverse events were collected from baseline (day 1, visit 1) and at all daily visits until termination visit (latest after 7 days). There was no follow-up after study termination.
Respiratory, thoracic and mediastinal disorders Aspiration	1.5% 1/67 • Adverse events were collected from baseline (day 1, visit 1) and at all daily visits until termination visit (latest after 7 days). There was no follow-up after study termination.
Surgical and medical procedures Intraabdominal bleeding	1.5% 1/67 • Adverse events were collected from baseline (day 1, visit 1) and at all daily visits until termination visit (latest after 7 days). There was no follow-up after study termination.

Other adverse events

Measure	Biatain Silicone Sacral Dressing n=67 participants at risk 67 patients were treated with Biatain Silicone Sacral dressing over the bony prominence of the sacral area as part of a pressure injury prevention protocol
Nervous system disorders Incision site pain	7.5% 5/67 • Number of events 5 • Adverse events were collected from baseline (day 1, visit 1) and at all daily visits until termination visit (latest after 7 days). There was no follow-up after study termination.

Additional Information

Senior Scientific Manager

Coloplast

Phone: +45 49112880

Email: dkcpov@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place