Use of a Microbial Sealant to Reduce Surgical Site Infections. (Integuseal)

Microbial Sealants Do Not Decrease Surgical Site Infection for Clean Contaminated Colorectal Procedures.

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).

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; SCIP
• Intervention / Treatment: Procedure: Open Colorectal Surgery; Procedure: Laparoscopic Surgery

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Los Angeles County/USC Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Nonemergent colon and/or rectal abdominal surgical procedures
2. Women of child-bearing potential must have a negative serum HCG assay prior to surgery
3. Ages ≥18 years.

Exclusion Criteria:

1. Known history of hypersensitivity to cyanoacrylate, formaldehyde or acetone products.
2. 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.

3. 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.

4. History of prior laparotomy within the last 60 days of this planned procedure.
5. Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure.
6. Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic shock (note that SIRS alone is not an exclusion criteria).6, 7
7. Preoperative severe neutropenia defined as total neutrophil count ≤500 × 106/L.
8. Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason.
9. Receiving antibiotic therapy within the 1 week prior to the date of surgery.
10. Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin.
11. Preoperative serum creatinine > 3 mg/dL or renal failure requiring dialysis.
12. History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.
13. History of major organ transplantation, including bone marrow transplantation.
14. 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.
15. Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).
16. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microbial Sealant; Integuseal (Kimberly Clark)	Procedure: Open Colorectal Surgery; Procedure: Laparoscopic Surgery
Sham Comparator: Control; No microbial sealant	Procedure: Open Colorectal Surgery; Procedure: Laparoscopic Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	15 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 months

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 13, 2014
• First Submitted That Met QC Criteria: September 13, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Estimate): September 16, 2014
• Last Update Submitted That Met QC Criteria: September 13, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: HS-10-00471