Use of a Microbial Sealant to Reduce Surgical Site Infections.

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02241915

Acronym

Integuseal

Enrollment

100

Registered

2014-09-16

Start date

2011-01-31

Completion date

Unknown

Last updated

2014-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SCIP, Surgical Site Infection

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).

Interventions

PROCEDUREOpen Colorectal Surgery

PROCEDURELaparoscopic Surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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. 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026