Phase 4 Evaluation of SurgiWrapTM to Minimize Soft Tissue Attachment & Reduce the Incidence of Early Post-Operative Bowel Obstruction in Colorectal Surgery
- Patient is 18 years of age or older of either gender
- Patient has primary diagnosis requiring a two-stage colectomy or procto-colectomy
- Patient or his/her legal representative has read and signed the Institutional Review
Board (IRB) approved Informed Consent form before randomization.
- Patient must be able and willing to follow study procedures and instructions.
- Patient is participating in another clinical study which may influence adhesion
- Patient has had barriers, solutions, or anti-adhesive therapy, other than
SurgiWrapTM, as planned at randomization, placed in the abdomen at the time of the
- Patient who, at the initial surgery, had administration of irrigants containing
corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs, or
- Patient has one or more medical condition(s), including severe renal, hepatic,
hematologic, neurologic, or immune disease that, in the opinion of the Investigator,
would make the patient an inappropriate candidate for this study.
- Patient is taking chronic (i.e., > 2 weeks) therapeutic doses of medications known to
affect healing such as nonsteroidal anti-inflammatory drugs. Prophylactic aspirin
(less than or equal to 325 mg once daily) for cardiovascular indications will be
permitted in patients.
- Patient has an infection in the intra-abdominal or pelvic area.