Clinical trial NCT05033470: A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers
Official title: A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers (DABIRPrU)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: SerenaGroup, Inc.
Sponsor class: NETWORK
Collaborators: name: Dabir Surfaces Inc
First posted: 2021-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-center prospective pilot study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

1. Subjects are male or female, 18 years of age or older.
2. Pressure ulcer/injury present for greater than 4 weeks (documented in the medical record).
3. 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.
4. Study ulcer is a minimum of 2.0 cm2 and a maximum of 50 cm2 at first treatment visit.
5. The subject is able and willing to follow the protocol requirements.
6. Subject has signed informed consent.

Exclusion Criteria

1. Subject has major uncontrolled medical disorder such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
2. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
3. The Subject has other concurrent conditions that, in the opinion of the Investigator, may compromise subject safety.
4. Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
5. Subject is pregnant or breast feeding.
6. 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.
7. 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.
8. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.
9. Known HbA1C \>12%.
10. Mini-nutritional assessment Malnutrition Indication score \<17.

Primary outcomes:
measure: Wound Reduction in Surface Area
timeFrame: 4 week
Secondary outcomes:
measure: Pain assessment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Butler
country: United States
facility: SunnyView
state: Pennsylvania
Study officials:
affiliation: cro
name: Laura Serena
role: STUDY_DIRECTOR
References: