SurgiWrapTM to Reduce Soft Tissue Attachment & Incidence Early Post-Operative Bowel Obstruction in Colorectal Surgery

Phase 4

Completed

• Conditions: Adhesions; Colectomy
• Interventions: Other: Polylactic Acid Sheet

• Registration Number: NCT00531739
• Lead Sponsor: Cytori Therapeutics

Brief Summary

The purpose of this study is to determine if the use of SurgiWrapTM: (1) prevents/lowers the incidence of Grade 2 or higher soft tissue attachments under the incision made during abdominal surgery, (2) reduces post-operative bowel obstruction.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Study First Posted: 2007-09-19
• Study Completion: 2009-07
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-05
• Last Update Posted: 2010-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• Patient is participating in another clinical study which may influence adhesion formation.
• 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 initial surgery
• Patient who, at the initial surgery, had administration of irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs, or dextran 70
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Polylactic Acid Sheet	Colorectal Surgery with use of SurgiWrapTM film secured in two study areas: the posterior pelvic rim and directly below the abdominal incision

Primary Outcome Measures

Name	Time	Method
Assess the efficacy of SurgiWrapTM in the prevention/reduction of Grade 2 or higher soft tissue attachments under the abdominal incision made during colorectal surgery	6 months

Secondary Outcome Measures

Name	Time	Method
Clinical and radiographic evidence of bowel obstruction	5 to 30 days
The incidence and extent of soft tissue attachments under the abdominal incision and on the pelvic floor after colorectal surgery	6 months

Trial Locations

Locations (1)

University of Southern California Norris Cancer Hospital; 🇺🇸 Los Angeles, California, United States