Status:
WITHDRAWN
Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Abdomenal Wound Trauma
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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- Patients who have participated in this trial previously and who were withdrawn.
Exclusion
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03431220
Start Date
December 1 2016
End Date
December 1 2017
Last Update
February 13 2018
Active Locations (1)
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1
Chicago, Illinois, United States, 60612