Use of a Microbial Sealant to Reduce Surgical Site Infections.

Surgical Site Infection Clinical Trial

— Integuseal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241915
• Other study ID #: HS-10-00471
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2014
• Last updated: September 13, 2014
• Start date: January 2011

Study information

• Verified date: September 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• SCIP
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Procedure:
• Open Colorectal Surgery

• Laparoscopic Surgery

Locations

Country	Name	City	State
United States	Los Angeles County/USC Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes