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

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT02241915
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection; SCIP	Procedure: Open Colorectal Surgery; Procedure: Laparoscopic Surgery	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Microbial Sealants Do Not Decrease Surgical Site Infection for Clean Contaminated Colorectal Procedures.
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: May 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

1. History of prior laparotomy within the last 60 days of this planned procedure.

2. Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure.

3. Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic shock (note that SIRS alone is not an exclusion criteria).6, 7

4. Preoperative severe neutropenia defined as total neutrophil count ≤500 × 106/L.

5. Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason.

6. Receiving antibiotic therapy within the 1 week prior to the date of surgery.

7. Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin.

8. Preoperative serum creatinine > 3 mg/dL or renal failure requiring dialysis.

9. History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.

10. History of major organ transplantation, including bone marrow transplantation.

11. 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.

12. Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).

13. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles County/USC Medical Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Doorly, Faculty Fellow, University of Southern California
• ClinicalTrials.gov Identifier: NCT02241915
• Other Study ID Numbers: HS-10-00471
• First Posted: Sep 16, 2014
• Last Update Posted: Sep 16, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection

Study Results

No Results Posted as of Sep 16, 2014