Use of a Microbial Sealant to Reduce Surgical Site Infections.

Phase 4

Completed

• Conditions: Surgical Site Infection; SCIP
• Interventions: Procedure: Open Colorectal Surgery; Procedure: Laparoscopic Surgery

• Registration Number: NCT02241915
• Lead Sponsor: University of Southern California

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 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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-05
• Status Verified: 2014-09
• Study First Submitted: 2014-09-13
• Study First Submitted QC: 2014-09-13
• Last Update Submitted: 2014-09-13
• Study First Posted: 2014-09-16
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Open Colorectal Surgery	No microbial sealant
Microbial Sealant	Open Colorectal Surgery	Integuseal (Kimberly Clark)
Microbial Sealant	Laparoscopic Surgery	Integuseal (Kimberly Clark)
Control	Laparoscopic Surgery	No microbial sealant

Primary Outcome Measures

Name	Time	Method
Incidence of SSI with and without microbial sealant.	15 Months	Determine the rate of SSI when microbial sealant (InteguSEAL© Kimberly-Clark) is used compared to control (no microbial sealant).

Secondary Outcome Measures

Name	Time	Method
Subgroup incidence of SSI with and without microbial sealant	15 months	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.

Trial Locations

Locations (1)

Los Angeles County/USC Medical Center; 🇺🇸 Los Angeles, California, United States