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

NCT00531739 | Completed Phase 4

• 1 other identifier: SURGIWRAP(TM)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesions; Colectomy

Keywords

Surgery; Colectomy; Proctocolectomy; Adhesions

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (2)

• Clinical and radiographic evidence of bowel obstruction

  5 to 30 days

• The incidence and extent of soft tissue attachments under the abdominal incision and on the pelvic floor after colorectal surgery

  6 months

Study Arms (2)

A

NO INTERVENTION

Colorectal Surgery without use of SurgiWrapTM

B

ACTIVE COMPARATOR

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

Interventions

Polylactic Acid Sheet OTHER

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.

Also known as: SurgiWrapTM

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cytori Therapeutics: lead

Study Sites (1)

University of Southern California Norris Cancer Hospital

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander M Milstein, MD

  Cytori Therapeutics

  STUDY DIRECTOR

• Robert Beard, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: March 1, 2006
• Study Completion: July 1, 2009
• Last Updated: October 7, 2010

Record last verified: 2010-10

Locations

US (1)