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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Unnamed facility
Chicago, Illinois, United States
To determine the number of days taken to achieve delayed primary fascial closure.
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.
Time frame: 14 days
To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain
Time frame: 14 days
To confirm the performance of the NPWT system in terms of: management of peritoneal fluid
Time frame: 14 days
To confirm the performance of the NPWT system in terms of reduction in edema
Time frame: 14 days
To confirm the performance of the NPWT system in terms of prevention of fixity
Time frame: 14 days
To confirm the performance of the NPWT system in terms of prevention of infection
Time frame: 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)
Time frame: 14 days
To determine the type (method) of final closure of the open abdomen
Time frame: 14 days
To assess the number of days to achieve final closure of the open abdomen
Time frame: 14 days
To monitor the length of stay (days) in ICU and length of stay in hospital
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Time frame: 14 days
To monitor the number and type of re-operations throughout the course of the study
Time frame: 14 days
To assess the number of dressing changes
Time frame: 14 days
To record clinicians' overall opinion on the usability of the new device throughout the study
Time frame: 14 days