Surgical Site Infection Clinical Trial
Official title:
Comparative Study of a Iodine + Cyanoacrylate (Integuseal) vs. Iodine and Isopropyl Alcohol in Skin Preparation for Prevention of Surgical Site Infections in Oncologic Surgery
The purpose if this study is to determine whether a microbial sealant (iodine + cyanoacrylate) [InteguSEAL®, Kimberly-Clark] reduces surgical site infections when compared to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) [Duraprep®] in oncologic surgery.
Patient's skin flora is a major source of pathogens, and microbial contamination of the
surgical site is a likely precursor of SSI. A variety of skin products may be used,
including iodophors, alcohol-containing products, and clorhexidine gluconate. Despite these
perioperative tactics, bacteria continue to survive at the skin level and migrate to
contaminate the wound.
A microbial sealant (InteguSEAL®, Kimberly-Clark) that uses cyanoacrylate to seal endogenous
skin flora has demonstrated to reduce wound contamination. The efficacy of the microbial
sealant in preventing SSI has been tested in cardiovascular surgery and open inguinal hernia
repair, with a reduction on SSI rate when compared to standard skin preparations. This
cyanoacrylate has not been tested in oncologic surgeries.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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