Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Open Abdomen
Interventions
DEVICE

AbCLO (Abdominal Wall Closure) Device

They will receive the standard of care (Lahey bag covering the bowel, 2 drains in the subcutaneous tissue and Ioban covering everything). The AbClO device has two Rectus Muscle Splints (RMS) to stabilize the rectus abdominis (preventing buckling of these muscles and stabilize the circumferential dynamic retainer (CDR)). The CDR is passed behind the patient's back. The RMSs are positioned on the abdominal wall approximately 2 cm lateral to the wound edges on each side. Additional padding can be applied underneath the RMS. The CDR is passed between the cross bar and the locking strip of each RMS and stretched until taut. The locking strips are locked in position. Four tensioners bridge across the OA from one RMS to the other. Gauze packs should be interposed between the undersurface of the tensioners and the surface of the temporary abdominal coverage to prevent friction. The Tensioners are tightened progressively until complete facial closure.

Trial Locations (2)

90033

Los Angeles County + University of Sothern California Medical Center, Los Angeles

02111

Tufts Medical center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

InentoRR MD

UNKNOWN

collaborator

LAC+USC Medical Center

OTHER

lead

Tufts Medical Center

OTHER