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

N

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)

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]

Trial contacts and locations

1

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Central trial contact

Diana Vilar-Compte, MD, MsC

Data sourced from clinicaltrials.gov

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