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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01110772
Recruitment Status : Unknown
Verified April 2010 by National Institute of Cancerología.
Recruitment status was:  Recruiting
First Posted : April 27, 2010
Last Update Posted : April 27, 2010
Kimberly-Clark de México
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Device: 2-octyl cyanoacrylate [InteguSEAL®] Device: Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M] Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparative Study of a Iodine + Cyanoacrylate (Integuseal) vs. Iodine and Isopropyl Alcohol in Skin Preparation for Prevention of Surgical Site Infections in Oncologic Surgery
Study Start Date : May 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 2-octyl cyanoacrylate
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.
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).
Other Name: InteguSEAL® (Kimberly Clark)

Active Comparator: iodine povacrylex in isopropyl alcohol
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.
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.
Other Name: Duraprep® (3M)

Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 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 :
  1. Cost analysis [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01110772

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Contact: Diana Vilar-Compte, MD, MsC +52 555 628 0400 ext 262

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National Institute of Cancerology Recruiting
Mexico City, DF, Mexico, 14080
Contact: Diana Vilar-Compte, MD, MsC    +52 555 628 0400 ext 262   
Sponsors and Collaborators
National Institute of Cancerología
Kimberly-Clark de México
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Principal Investigator: Diana Vilar-Compte, MD;MsC Instituto Nacional de Cancerologia, Columbia

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Responsible Party: Diana Vilar-Compte, MD, MsC, Departmentof Infectious Diseases. Instituto Nacional de Cancerología Identifier: NCT01110772     History of Changes
Other Study ID Numbers: 09003INI
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010
Keywords provided by National Institute of Cancerología:
Surgical site infection
Skin preparation
Cost analysis
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Trace Elements
Growth Substances