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

Smith & Nephew

Status

Withdrawn

Conditions

Abdomenal Wound Trauma

Treatments

Device: RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03431220

305-001-001-01

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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Patients who have participated in this trial previously and who were withdrawn.