A Phase 4 interventional study of Open Colorectal Surgery and Laparoscopic Surgery in Surgical Site Infection and SCIP, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-16.
Sponsored by University of Southern California · Phase 4, Interventional, and Prevention
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).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Undergoing a significant concomitant surgical procedure (e.g., Whipple \& organ transplant surgery).
The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, liver biopsy/wedge resection (but not liver resection), cystectomy.
Integuseal (Kimberly Clark)
Procedure: Open Colorectal Surgery · Procedure: Laparoscopic Surgery
No microbial sealant
Procedure: Open Colorectal Surgery · Procedure: Laparoscopic Surgery
Incidence of SSI with and without microbial sealant.
Determine the rate of SSI when microbial sealant (InteguSEAL© Kimberly-Clark) is used compared to control (no microbial sealant).
Time frame: 15 Months
Subgroup incidence of SSI with and without microbial sealant
Compare SSI for open vs. laparoscopy colectomy, age, BMI, diabetes and morbidity (ASA class), hospital readmission, reoperation and wound dehiscence with and without microbial sealant.
Time frame: 15 months
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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University of Southern California