Use of a Microbial Sealant to Reduce Surgical Site Infections.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Surgical Site Infection SCIP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Microbial Sealant

Integuseal (Kimberly Clark)

Group Type ACTIVE_COMPARATOR

Open Colorectal Surgery

Intervention Type PROCEDURE

Laparoscopic Surgery

Intervention Type PROCEDURE

Control

No microbial sealant

Group Type SHAM_COMPARATOR

Open Colorectal Surgery

Intervention Type PROCEDURE

Laparoscopic Surgery

Intervention Type PROCEDURE

Interventions

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Open Colorectal Surgery

Intervention Type PROCEDURE

Laparoscopic Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes