Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure

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.

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 Patients who have participated in this trial previously and who were withdrawn.