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

NCT01110772 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2010-04-27

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection

Interventions

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.

Sponsors & Collaborators

  • Kimberly-Clark de México

    collaborator UNKNOWN

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • Diana Vilar-Compte, MD;MsC · Instituto Nacional de Cancerologia, Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01110772 on ClinicalTrials.gov