Clinical trial NCT03431220: Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Abdomenal Wound Trauma
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: INCLUSION CRITERIA

1. 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.
2. Subjects must be at least eighteen (18) yeaTS of age, or older.
3. Males and non-pregnant females.
4. 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

1. Grade 3 and Grade 4 open abdomens.
2. Malignancy in the reference wound bed or margins of the wound.
3. Patients with non-enteric unexplored fistulas.
4. High risk for imminent death, as determined by the attending surgeon and Principal Investigator (PI).
5. Pre-existing large ventral hernia.
6. Significant loss of abdominal wall fascia as a result of trauma or infection.
7. Patients with a known hist01y of poor compliance with medical treatment.
8. Patients who have participated in this trial previously and who were withdrawn.

Primary outcomes:
measure: To determine the number of days taken to achieve delayed primary fascial closure.
timeFrame: 14 days
Secondary outcomes:
measure: To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain
timeFrame: 14 days
measure: To confirm the performance of the NPWT system in terms of: management of peritoneal fluid
timeFrame: 14 days
measure: To confirm the performance of the NPWT system in terms of reduction in edema
timeFrame: 14 days
measure: To confirm the performance of the NPWT system in terms of prevention of fixity
timeFrame: 14 days
measure: To confirm the performance of the NPWT system in terms of prevention of infection
timeFrame: 14 days
measure: To assess the ability of the NPWT system to prevent further deterioration of the open abdomen as classified by Bjorck et al., (2009)
timeFrame: 14 days
measure: To determine the type (method) of final closure of the open abdomen
timeFrame: 14 days
measure: To assess the number of days to achieve final closure of the open abdomen
timeFrame: 14 days
measure: To monitor the length of stay (days) in ICU and length of stay in hospital
timeFrame: 14 days
measure: To monitor the number and type of re-operations throughout the course of the study
timeFrame: 14 days
measure: To assess the number of dressing changes
timeFrame: 14 days
measure: To record clinicians' overall opinion on the usability of the new device throughout the study
timeFrame: 14 days
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
Study officials:
affiliation: Smith & Nephew, Inc.
name: Jaime E Dickerson, PhD
role: STUDY_CHAIR
References: