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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00531739
Other study ID # SURGIWRAP(TM)
Secondary ID
Status Completed
Phase Phase 4
First received September 18, 2007
Last updated October 5, 2010
Start date March 2006
Est. completion date July 2009

Study information

Verified date October 2010
Source Cytori Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Southern California Norris Cancer Hospital Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cytori Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Clinical and radiographic evidence of bowel obstruction 5 to 30 days
Secondary The incidence and extent of soft tissue attachments under the abdominal incision and on the pelvic floor after colorectal surgery 6 months
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