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

This study has been completed.
Sponsor:
Information provided by:
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT00531739
First received: September 18, 2007
Last updated: October 5, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Adhesions
Colectomy
Other: Polylactic Acid Sheet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cytori Therapeutics:

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

Estimated Enrollment: 60
Study Start Date: March 2006
Study Completion Date: July 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531739

Locations
United States, California
University of Southern California Norris Cancer Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Cytori Therapeutics
Investigators
Study Director: Alexander M Milstein, MD Cytori Therapeutics
Principal Investigator: Robert Beard, MD University of Southern California
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00531739     History of Changes
Other Study ID Numbers: SURGIWRAP(TM)
Study First Received: September 18, 2007
Last Updated: October 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cytori Therapeutics:
Surgery
Colectomy
Proctocolectomy
Adhesions

Additional relevant MeSH terms:
Tissue Adhesions
Intestinal Obstruction
Cicatrix
Fibrosis
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014