Use of a Microbial Sealant to Reduce Surgical Site Infections.
NCT02241915 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2014-09-16
Summary
Surgical site infections (SSI) are costly complications that may cause significant morbidity and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS) are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we hypothesized that a microbial sealant could reduce the rate of SSI by half for clean contaminated colorectal procedures (Class 2).
Conditions
- Surgical Site Infection
- SCIP
Interventions
- PROCEDURE
-
Open Colorectal Surgery
- PROCEDURE
-
Laparoscopic Surgery
Sponsors & Collaborators
-
University of Southern California
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2012-05-31
Countries
- United States
Study Locations
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