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ALLEVYN Complete Care for Bedsores

(PACCT Trial)

Not yet recruiting at 2 trial locations
JD
LE
Overseen ByLaura Everson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Smith & Nephew, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to investigate the use of ALLEVYN◊ COMPLETE CARE Sacrum dressing for the prevention of hospital-acquired pressure injuries in adults. The main question it aims to answer is whether or not the dressing will prevent pressure injury prevention between application and Day 7. Participants will apply a dressing to the lower back/tailbone area as part of their regular care up to 14 days and participate in ongoing checkups by the study team.

Who Is on the Research Team?

AS

Amanda Spitzer, MBA, RN

Principal Investigator

Smith & Nephew, Inc.

Are You a Good Fit for This Trial?

This trial is for adults in critical care units who are at risk of developing bedsores (pressure injuries) on their lower back or tailbone. People already having pressure sores, allergies to dressings, or certain skin conditions may not be able to join.

Inclusion Criteria

Subject or legally authorized representative (LAR) provides written informed consent
I am 18 years old or older.
Willing and able to complete all required study visits
See 5 more

Exclusion Criteria

Subject has participated previously in this clinical trial
I have a skin injury or irregularity on my lower back area.
Subject has a medical or physical condition that would preclude safe participation in the study (Investigator opinion)
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • ALLEVYN◊ COMPLETE CARE Sacrum

Trial Overview

The study tests whether using the ALLEVYN COMPLETE CARE Sacrum dressing on the lower back/tailbone can help prevent new bedsores in high-risk patients over up to 14 days, compared with standard care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ALLEVYN◊ COMPLETE CARE SacrumExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Smith & Nephew, Inc.

Lead Sponsor

Trials
176
Recruited
23,500+
Dr. Maria Berkman profile image

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath profile image

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

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