NCT01110772

Comparison of Iodine + Isopropyl Alcohol Versus Iodine + Antimicrobial Sealant for Skin Preparation

Comparative Study of a Iodine + Cyanoacrylate (Integuseal) vs. Iodine and Isopropyl Alcohol in Skin Preparation for Prevention of Surgical Site Infections in Oncologic Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: National Institute of Cancerología · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DEVICE	2-octyl cyanoacrylate [InteguSEAL®]	At operating room arrival prior to surgery, povidone-iodine is applied on the skin surface on concentric circles as recommended; after drying, the cyanoacrylate device is opened and a layer of the sealant is applied on the incision and skin site(IS100 for patients undergoing mastectomy, and IS200 for patients undergoing gynecologic or digestive tract surgeries).
DEVICE	Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]	At the operating room arrival a few minutes before the incision, cleansing and skin antisepsis is done with the prefilled device with iodine povacrylex in isopropyl alcohol as recommended by 3M.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-10-01
• Completion: 2010-12-01
• First posted: 2010-04-27
• Last updated: 2010-04-27

Locations

1 site across 1 country: Mexico