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

Colectomy Clinical Trial

Official title:

Phase 4 Evaluation of SurgiWrapTM to Minimize Soft Tissue Attachment & Reduce the Incidence of Early Post-Operative Bowel Obstruction in Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531739
• Other study ID #: SURGIWRAP(TM)
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Adhesions
• Colectomy
• Intestinal Obstruction

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