Status:
COMPLETED
Use of a Microbial Sealant to Reduce Surgical Site Infections.
Lead Sponsor:
University of Southern California
Conditions:
Surgical Site Infection
SCIP
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- Nonemergent colon and/or rectal abdominal surgical procedures
- Women of child-bearing potential must have a negative serum HCG assay prior to surgery
- Ages ≥18 years.
Exclusion
- Known history of hypersensitivity to cyanoacrylate, formaldehyde or acetone products.
- Undergoing emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed). Emergency surgery includes cases where standard bowel preparation and other preoperative assessments cannot be done.
- 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.
- History of prior laparotomy within the last 60 days of this planned procedure.
- Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure.
- Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic shock (note that SIRS alone is not an exclusion criteria).6, 7
- Preoperative severe neutropenia defined as total neutrophil count ≤500 × 106/L.
- Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason.
- Receiving antibiotic therapy within the 1 week prior to the date of surgery.
- Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin.
- Preoperative serum creatinine \> 3 mg/dL or renal failure requiring dialysis.
- History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.
- History of major organ transplantation, including bone marrow transplantation.
- Taking systemic steroids \>10 mg prednisone daily or remicade within 2 weeks prior to surgery or a history of a current immunosuppressive condition (eg, symptomatic HIV infection), defined as a CD4 count \< 200.
- Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).
- Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02241915
Start Date
January 1 2011
Last Update
September 16 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles County/USC Medical Center
Los Angeles, California, United States, 90033