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

Cytori Therapeutics

Status and phase: Completed; Phase 4

Conditions: Adhesions; Colectomy

Treatments: Other: Polylactic Acid Sheet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00531739

SURGIWRAP(TM)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

A

No Intervention group

Description:

Colorectal Surgery without use of SurgiWrapTM

B

Active Comparator group

Description:

Colorectal Surgery with use of SurgiWrapTM film secured in two study areas: the posterior pelvic rim and directly below the abdominal incision

Treatment:

Other: Polylactic Acid Sheet