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

NCT05033470 | Unknown DMC

• 1 other identifier: DABITPrU-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• Wound Reduction in Surface Area

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

  4 week

Secondary Outcomes (1)

• Pain assessment

  4 weeks

Study Arms (1)

Dabir Surface Mattress Overlay System

EXPERIMENTAL

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.

Device: Dabir Mattress Overlay System

Interventions

Dabir Mattress Overlay System DEVICE

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.

Also known as: standard of care

Dabir Surface Mattress Overlay System

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• Dabir Surfaces Inc: collaborator

Study Sites (1)

SunnyView

Butler, Pennsylvania, 16001, United States

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Serena

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  STUDY DIRECTOR

Central Study Contacts

Thomas Serena, MD, FACS

CONTACT

814-688-4000; serena@serenagroups.com

Kristy Breisinger

CONTACT

412-212-0123; kbreisinger@serenagroups.com

Study Design

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

Model Details: Multi-center prospective pilot study

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: September 2, 2021
• Study Start: October 4, 2021
• Primary Completion: May 1, 2023
• Study Completion: June 30, 2023
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

US (1)