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


Phase 4
18 Years
N/A
Not Enrolling
Both
Adhesions, Colectomy

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome 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

Outcome Time Frame:

6 months

Principal Investigator

Alexander M Milstein, MD

Investigator Role:

Study Director

Investigator Affiliation:

Cytori Therapeutics

Authority:

United States: Institutional Review Board

Study ID:

SURGIWRAP(TM)

NCT ID:

NCT00531739

Start Date:

March 2006

Completion Date:

July 2009

Related Keywords:

  • Adhesions
  • Colectomy
  • Surgery
  • Colectomy
  • Proctocolectomy
  • Adhesions
  • Tissue Adhesions
  • Intestinal Obstruction

Name

Location

University of Southern California Norris Cancer HospitalLos Angeles, California  90033