Clinical trial NCT00531739: SurgiWrapTM to Reduce Soft Tissue Attachment & Incidence Early Post-Operative Bowel Obstruction in Colorectal Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adhesions
Colectomy
Keywords: Surgery
Colectomy
Proctocolectomy
Adhesions
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Clinical and radiographic evidence of bowel obstruction
timeFrame: 5 to 30 days
measure: The incidence and extent of soft tissue attachments under the abdominal incision and on the pelvic floor after colorectal surgery
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Norris Cancer Hospital
state: California
Study officials:
affiliation: Cytori Therapeutics
name: Alexander M Milstein, MD
role: STUDY_DIRECTOR
affiliation: University of Southern California
name: Robert Beard, MD
role: PRINCIPAL_INVESTIGATOR
References: