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

NCT ID: NCT00531739

Last Updated: 2010-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-07-31

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.

Conditions

Adhesions; Colectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A

Colorectal Surgery without use of SurgiWrapTM

Group Type: NO_INTERVENTION

No interventions assigned to this group

B

Colorectal Surgery with use of SurgiWrapTM film secured in two study areas: the posterior pelvic rim and directly below the abdominal incision

Group Type: ACTIVE_COMPARATOR

Polylactic Acid Sheet

Intervention Type: OTHER

SurgiWrapTM film will be secured in two study areas: directly below the abdominal incision and on the posterior pelvic rim. The film will not be wrapped directly around an anastomosis.

Interventions

Polylactic Acid Sheet

SurgiWrapTM film will be secured in two study areas: directly below the abdominal incision and on the posterior pelvic rim. The film will not be wrapped directly around an anastomosis.

Intervention Type: OTHER

Other Intervention Names

SurgiWrapTM

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytori Therapeutics

INDUSTRY

Sponsor Role: lead

Principal Investigators

Alexander M Milstein, MD

Role: STUDY_DIRECTOR

Cytori Therapeutics

Robert Beard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California Norris Cancer Hospital

Los Angeles, California, United States

Countries

United States

Other Identifiers

SURGIWRAP(TM)

Identifier Type: -

Identifier Source: org_study_id