Back to results

A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers (DABIRPrU)

Primary Purpose

Pressure Ulcer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dabir Mattress Overlay System

About this trial

This is an interventional treatment trial for Pressure Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Subjects are male or female, 18 years of age or older.
Pressure ulcer/injury present for greater than 4 weeks (documented in the medical record).
Subject has clinical documentation of no visible wound improvement in the post four weeks of standard of care. Objectively, less than 20% healing in the past four weeks from the first treatment visit.
Study ulcer is a minimum of 2.0 cm2 and a maximum of 50 cm2 at first treatment visit.
The subject is able and willing to follow the protocol requirements.
Subject has signed informed consent.

Exclusion Criteria

Subject has major uncontrolled medical disorder such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
The Subject has other concurrent conditions that, in the opinion of the Investigator, may compromise subject safety.
Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
Subject is pregnant or breast feeding.
Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the l 30 days preceding the first treatment visit.
Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.
Known HbA1C >12%.
Mini-nutritional assessment Malnutrition Indication score <17.

Sites / Locations

SunnyViewRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dabir Surface Mattress Overlay System

Arm Description

Eligible patients are treated with a mattress overlay system and standard of care (debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling). Subjects will be seen weekly for 4 weeks. Patients who respond to the offloading device, may use the overlay for an additional 12 weeks with monthly follow-up visits in the clinic or their home. Subjects undergo study procedures on a weekly basis.

Outcomes

Primary Outcome Measures

Wound Reduction in Surface Area

The percentage change in ulcer size (wound area reduction) from baseline to 4 week completion

Secondary Outcome Measures

Pain assessment

Assessment of the pain level linked to the wound, using a numeric pain scale. Numeric Pain Scale from 0-10 anchored by word descriptors at each end. A numerical scale will be used to assess pain. Subject will be asked to indicate a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by "word descriptors" at each end, as "no pain" on the left side and "worst possible pain" on the right side of the number line. The number 0 represents "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain". The subject indicates the level of pain intensity by selecting a number on the line that represents their perception of their current state.

Full Information

NCT ID

NCT05033470

First Posted

August 13, 2021

Last Updated

November 3, 2022

Sponsor

SerenaGroup, Inc.

Collaborators

Dabir Surfaces Inc

1. Study Identification

Unique Protocol Identification Number

NCT05033470

Brief Title

A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers

Acronym

DABIRPrU

Official Title

A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers (DABIRPrU)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 4, 2021 (Actual)

Primary Completion Date

May 1, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SerenaGroup, Inc.

Collaborators

Dabir Surfaces Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate the use of a mattress overlay system to promote the healing of full thickness pressure ulcers. The overlay is placed over the patient's bed making it easier for patients to get in and out of bed. In addition, the overlay has blue tooth capabilities that will allow clinicians to remotely monitor adherence with the device.

Detailed Description

The study is a multi-center, prospective, study designed to evaluate the use of an alternating mattress overlay in the treatment of stage 3 pressure ulcers. After screening, eligible subjects will receive a mattress overlay system for the 4 weeks of treatment. The mattress is fitted to the patient's bed/mattress in his/her home or skilled nursing facility (SNF). Patients responding to the offloading regimen (percent wound area reduction >20% at 4 weeks) may use the overlay for up to 12 additional weeks. The SOC in this study is debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pressure Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Multi-center prospective pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dabir Surface Mattress Overlay System

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Dabir Mattress Overlay System

Other Intervention Name(s)

standard of care

Intervention Description

Dabir Surface mattress overlay system consists of a controller and a low-profile alternating pressure (AP) surface (placed over a non-powered mattress) with hundreds of air-filled geometric nodes arranged in rows. . The multiple rows of nodes inflate and deflate in alternating sequence every five minutes. During deflation phase, the skin and soft tissues experience reduced pressure/loading and enhanced perfusion. In conjunction with Standard of Care: Debridement, Proper moisture balance, off-loading, reduce bacterial burden and nutritional counseling.

Primary Outcome Measure Information:

Title

Wound Reduction in Surface Area

Description

The percentage change in ulcer size (wound area reduction) from baseline to 4 week completion

Time Frame

4 week

Secondary Outcome Measure Information:

Title

Pain assessment

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Subjects are male or female, 18 years of age or older. Pressure ulcer/injury present for greater than 4 weeks (documented in the medical record). Subject has clinical documentation of no visible wound improvement in the post four weeks of standard of care. Objectively, less than 20% healing in the past four weeks from the first treatment visit. Study ulcer is a minimum of 2.0 cm2 and a maximum of 50 cm2 at first treatment visit. The subject is able and willing to follow the protocol requirements. Subject has signed informed consent. Exclusion Criteria Subject has major uncontrolled medical disorder such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound. The Subject has other concurrent conditions that, in the opinion of the Investigator, may compromise subject safety. Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study. Subject is pregnant or breast feeding. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the l 30 days preceding the first treatment visit. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1. Known HbA1C >12%. Mini-nutritional assessment Malnutrition Indication score <17.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Serena, MD, FACS

Phone

814-688-4000

serena@serenagroups.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kristy Breisinger

Phone

412-212-0123

kbreisinger@serenagroups.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Serena

Organizational Affiliation

cro

Official's Role

Study Director

Facility Information:

Facility Name

SunnyView

City

Butler

State/Province

Pennsylvania

ZIP/Postal Code

16001

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Serena

lserena@serenagroups.com

12. IPD Sharing Statement

Learn more about this trial

A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers

We'll reach out to this number within 24 hrs