NCT02241915

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

September 13, 2014

Last Update Submit

September 13, 2014

Conditions

Surgical Site InfectionSCIP

Outcome Measures

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).

    15 Months

Secondary Outcomes (1)

  • Subgroup incidence of SSI with and without microbial sealant

    15 months

Study Arms (2)

Microbial Sealant

ACTIVE COMPARATOR

Integuseal (Kimberly Clark)

Procedure: Open Colorectal SurgeryProcedure: Laparoscopic Surgery

Control

SHAM COMPARATOR

No microbial sealant

Procedure: Open Colorectal SurgeryProcedure: Laparoscopic Surgery

Interventions

Open Colorectal SurgeryPROCEDURE
ControlMicrobial Sealant
Laparoscopic SurgeryPROCEDURE
ControlMicrobial Sealant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known history of hypersensitivity to cyanoacrylate, formaldehyde or acetone products.
  • 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.
  • 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.
  • History of prior laparotomy within the last 60 days of this planned procedure.
  • Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure.
  • Preoperative severe neutropenia defined as total neutrophil count ≤500 × 106/L.
  • Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason.
  • Receiving antibiotic therapy within the 1 week prior to the date of surgery.
  • Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin.
  • Preoperative serum creatinine \> 3 mg/dL or renal failure requiring dialysis.
  • History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.
  • History of major organ transplantation, including bone marrow transplantation.
  • 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.
  • Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles County/USC Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Fellow

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 16, 2014

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

US(1)