NCT00947089CompletedPhase 4
The Role of Oxidized Regenerated Cellulose in Preventing Infections at the Surgical Site: Prospective, Randomized Study in 98 Patients Affected by a Dirty Wound
Catholic University of the Sacred Heart2 sites in 1 country98 target enrollmentStarted: December 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 98
- Locations
- 2
- Primary Endpoint
- to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment
Study Overview
Brief Summary
The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is effective to reduce the risk of surgical site infections (SSI).
Detailed Description
Surgical site infections (SSI) have significant clinical and economic repercussions since they still are the most common cause of nosocomial infections in surgical patients. It is important to bear in mind the growing number of SSI due to antibiotic-resistant microorganisms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •have an ileostomy or a colostomy
- •are candidates for an elective surgical procedure of ostomy closure
Exclusion Criteria
- •immunodeficiency
- •chronic use of corticosteroids or antibiotics
- •chemotherapy and/or radiotherapy in the last 30 days before closure of the stoma
- •concomitant foci of infection
Outcomes
Primary Outcomes
to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment
Time Frame: third post-operative day
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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