CompletedPhase 4

Use of a Microbial Sealant to Reduce Surgical Site Infections.

United States100 participantsStarted 2011-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

Incidence of SSI with and without microbial sealant.

Timeframe: 15 Months

Trial details

NCT IDNCT02241915

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Surgical Site Infection trials