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

Phase 4

• Conditions: Surgical Site Infection
• Interventions: Device: 2-octyl cyanoacrylate [InteguSEAL®]; Device: Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]

• Registration Number: NCT01110772
• Lead Sponsor: National Institute of Cancerología

Brief 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.

Study Timeline

• Study Start: 2009-05
• Status Verified: 2010-04
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Last Update Submitted: 2010-04-26
• Study First Posted: 2010-04-27
• Last Update Posted: 2010-04-27
• Primary Completion: 2010-10
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Patients >= 18 years undergoing elective clean or clean-contaminated breast, gynecologic or digestive tract surgery
• Accepts to participate and signs the informed consent form
• Have a telephone number to be contacted after surgery

Exclusion Criteria

• Previous allergy to one of the study products
• Two or more procedures in different anatomical sites at the same time / surgery (v.g. hysterectomy and mastectomy)
• Pregnancy
• Breast feeding
• Contaminated or infected surgeries

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-octyl cyanoacrylate	2-octyl cyanoacrylate [InteguSEAL®]	As recommended, povidone iodine is used for skin antisepsis. After drying, a layer of cyanoacrylate is applied on the skin surface with the purpose of immobilizing skin bacteria.
iodine povacrylex in isopropyl alcohol	Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]	Iodine povacrylex in isopropyl alcohol (Duraprep 3M) This is considered a standard of care in our hospital as many other institutions. It's efficacy and safety have been demonstrated.

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30-45 days	Patients we'll be followed prospectively by direct observation to evaluate if a surgical infection occurs. After 30 days of follow-up, patients will be classified as having or not a surgical site infection using the CDC criteria.

Secondary Outcome Measures

Name	Time	Method
Cost analysis	30-45 days	We'll be doing a cost-efectiveness analysis at the end of the study considering the treatment arm, complications developed from surgery to end of follow-up and costs for its treatment.

Trial Locations

Locations (1)

National Institute of Cancerology; 🇲🇽 Mexico City, DF, Mexico