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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Institute of Cancerología.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Kimberly-Clark de México
Information provided by:
National Institute of Cancerología
ClinicalTrials.gov Identifier:
NCT01110772
First received: April 23, 2010
Last updated: April 26, 2010
Last verified: April 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Cancerología:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 30-45 days ] [ Designated as safety issue: No ]
    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:
  • Cost analysis [ Time Frame: 30-45 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: May 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110772

Contacts
Contact: Diana Vilar-Compte, MD, MsC +52 555 628 0400 ext 262 parakalomx@yahoo.com.mx

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

No publications provided

Responsible Party: Diana Vilar-Compte, MD, MsC, Departmentof Infectious Diseases. Instituto Nacional de Cancerología
ClinicalTrials.gov Identifier: NCT01110772     History of Changes
Other Study ID Numbers: 09003INI
Study First Received: April 23, 2010
Last Updated: April 26, 2010
Health Authority: Mexico: Ethics Committee

Keywords provided by National Institute of Cancerología:
Surgical site infection
Skin preparation
Cost analysis

Additional relevant MeSH terms:
Ethanol
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013