- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03431220
Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
6. februar 2018 opdateret af: Smith & Nephew, Inc.
A Prospective, Non-Comparative, Open, Multi-Center Study to Assess the Use of a New Negative Pressure Wound Therapy (NPWT) System (RENASYS Touch and RENASYS AB) in Temporary Abdominal Closure (TAC) For the Management of the Open Abdomen
A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure.
Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up assessment for latent complications and mortality.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Illinois
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Chicago, Illinois, Forenede Stater, 60612
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
INCLUSION CRITERIA
- Eligible subjects must be properly consented before enrollment. If the subject is incapable of providing consent, emergency consent procedures will be followed, or the subject's legal representative must be asked to provide consent on the subject's behalf, per the IRB guidelines.
- Subjects must be at least eighteen (18) yeaTS of age, or older.
- Males and non-pregnant females.
- Grade 1 or Grade 2 open abdomen patients who would benefit from temporary abdominal closure (TAC) with topical Negative Pressure Wound Therapy (NPWT).
EXCLUSION CRITERIA
- Grade 3 and Grade 4 open abdomens.
- Malignancy in the reference wound bed or margins of the wound.
- Patients with non-enteric unexplored fistulas.
- High risk for imminent death, as determined by the attending surgeon and Principal Investigator (PI).
- Pre-existing large ventral hernia.
- Significant loss of abdominal wall fascia as a result of trauma or infection.
- Patients with a known hist01y of poor compliance with medical treatment.
- Patients who have participated in this trial previously and who were withdrawn.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: RENASYS TOUCH NPWT System
Negative Pressure Wound Therapy (NPWT)
|
NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To determine the number of days taken to achieve delayed primary fascial closure.
Tidsramme: 14 days
|
NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.
|
14 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain
Tidsramme: 14 days
|
14 days
|
To confirm the performance of the NPWT system in terms of: management of peritoneal fluid
Tidsramme: 14 days
|
14 days
|
To confirm the performance of the NPWT system in terms of reduction in edema
Tidsramme: 14 days
|
14 days
|
To confirm the performance of the NPWT system in terms of prevention of fixity
Tidsramme: 14 days
|
14 days
|
To confirm the performance of the NPWT system in terms of prevention of infection
Tidsramme: 14 days
|
14 days
|
To assess the ability of the NPWT system to prevent further deterioration of the open abdomen as classified by Bjorck et al., (2009)
Tidsramme: 14 days
|
14 days
|
To determine the type (method) of final closure of the open abdomen
Tidsramme: 14 days
|
14 days
|
To assess the number of days to achieve final closure of the open abdomen
Tidsramme: 14 days
|
14 days
|
To monitor the length of stay (days) in ICU and length of stay in hospital
Tidsramme: 14 days
|
14 days
|
To monitor the number and type of re-operations throughout the course of the study
Tidsramme: 14 days
|
14 days
|
To assess the number of dressing changes
Tidsramme: 14 days
|
14 days
|
To record clinicians' overall opinion on the usability of the new device throughout the study
Tidsramme: 14 days
|
14 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Jaime E Dickerson, PhD, Smith & Nephew, Inc.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. december 2016
Primær færdiggørelse (Forventet)
1. november 2017
Studieafslutning (Forventet)
1. december 2017
Datoer for studieregistrering
Først indsendt
17. november 2016
Først indsendt, der opfyldte QC-kriterier
6. februar 2018
Først opslået (Faktiske)
13. februar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 305-001-001-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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