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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00531739
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : October 7, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Adhesions Colectomy Other: Polylactic Acid Sheet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Evaluation of SurgiWrapTM to Minimize Soft Tissue Attachment & Reduce the Incidence of Early Post-Operative Bowel Obstruction in Colorectal Surgery
Study Start Date : March 2006
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: A
Colorectal Surgery without use of SurgiWrapTM
Active Comparator: B
Colorectal Surgery with use of SurgiWrapTM film secured in two study areas: the posterior pelvic rim and directly below the abdominal incision
Other: 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.
Other Name: SurgiWrapTM

Primary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Clinical and radiographic evidence of bowel obstruction [ Time Frame: 5 to 30 days ]
  2. The incidence and extent of soft tissue attachments under the abdominal incision and on the pelvic floor after colorectal surgery [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00531739

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United States, California
University of Southern California Norris Cancer Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Cytori Therapeutics
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Study Director: Alexander M Milstein, MD Cytori Therapeutics
Principal Investigator: Robert Beard, MD University of Southern California
Layout table for additonal information Identifier: NCT00531739    
Other Study ID Numbers: SURGIWRAP(TM)
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: October 2010
Keywords provided by Cytori Therapeutics:
Additional relevant MeSH terms:
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Intestinal Obstruction
Tissue Adhesions
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases