CClinicalTrials.gg
CompletedNCT02241915IntegusealUpdated Sep 16, 2014

Use of a Microbial Sealant to Reduce Surgical Site Infections.

A Phase 4 interventional study of Open Colorectal Surgery and Laparoscopic Surgery in Surgical Site Infection and SCIP, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-16.

Sponsored by University of Southern California · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureOpen Colorectal Surgery
  • ProcedureLaparoscopic Surgery
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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 15 Months

Secondary outcomes

  1. 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.

    Time frame: 15 months

07

Study locations

1 site
  • Los Angeles County/USC Medical Center
    Los Angeles, California 90033, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02241915
Lead sponsor
University of Southern California
Responsible party
Michael Doorly (Faculty Fellow, University of Southern California) — Principal investigator
First posted
Sep 16, 2014
Start date
Jan 2011
Primary completion
May 2012
Last update
Sep 16, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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