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

National Institute of Cancerología

Status and phase: Unknown; Phase 4

Conditions: Surgical Site Infection

Treatments: Device: 2-octyl cyanoacrylate [InteguSEAL®]; Device: Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]

Study type: Interventional

Funder types: Other

Identifiers

NCT01110772

09003INI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

2-octyl cyanoacrylate

Experimental group

Description:

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.

Treatment:

Device: 2-octyl cyanoacrylate [InteguSEAL®]

iodine povacrylex in isopropyl alcohol

Active Comparator group

Description:

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.

Treatment:

Device: Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]