An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery

Integra LifeSciences

Status: Terminated

Conditions: Familial Polyposis; Ulcerative Colitis

Treatments: Device: SprayShield Adhesion Barrier System; Procedure: Good Surgical Technique Alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01002287

ABD-08-001

Details and patient eligibility

About

This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

SprayShield Adhesion Barrier

Experimental group

Description:

SprayShield Adhesion Barrier

Treatment:

Device: SprayShield Adhesion Barrier System

Control

Sham Comparator group

Description:

Good Surgical Technique Alone

Treatment:

Procedure: Good Surgical Technique Alone