A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers (DABIRPrU)
3. november 2022 oppdatert av: SerenaGroup, Inc.
A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers (DABIRPrU)
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kristy Breisinger
- Telefonnummer: 412-212-0123
- E-post: kbreisinger@serenagroups.com
Studiesteder
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Pennsylvania
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Butler, Pennsylvania, Forente stater, 16001
- Rekruttering
- Sunnyview
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Ta kontakt med:
- Laura Serena
- E-post: lserena@serenagroups.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Dabir Surface Mattress Overlay System
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.
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Wound Reduction in Surface Area
Tidsramme: 4 week
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The percentage change in ulcer size (wound area reduction) from baseline to 4 week completion
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4 week
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain assessment
Tidsramme: 4 weeks
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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.
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4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Laura Serena, CRO
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. oktober 2021
Primær fullføring (Forventet)
1. mai 2023
Studiet fullført (Forventet)
30. juni 2023
Datoer for studieregistrering
Først innsendt
13. august 2021
Først innsendt som oppfylte QC-kriteriene
27. august 2021
Først lagt ut (Faktiske)
2. september 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. november 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. november 2022
Sist bekreftet
1. november 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DABITPrU-001
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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