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

NCT01110772 | Unknown Phase 4

• 1 other identifier: 09003INI
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

Surgical site infection; Skin preparation; Cost analysis

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  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.

  30-45 days

Secondary Outcomes (1)

• Cost analysis

  30-45 days

Study Arms (2)

2-octyl cyanoacrylate

EXPERIMENTAL

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®]

iodine povacrylex in isopropyl alcohol

ACTIVE COMPARATOR

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]

Interventions

2-octyl cyanoacrylate [InteguSEAL®] DEVICE

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).

Also known as: InteguSEAL® (Kimberly Clark)

2-octyl cyanoacrylate

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

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.

Also known as: Duraprep® (3M)

iodine povacrylex in isopropyl alcohol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cancerología: lead
• Kimberly-Clark de México: collaborator

Study Sites (1)

National Institute of Cancerology

Mexico City, Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diana Vilar-Compte, MD;MsC

  Instituto Nacional de Cancerologia, Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Vilar-Compte, MD, MsC

CONTACT

+52 555 628 0400; parakalomx@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 27, 2010
• Study Start: May 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 27, 2010

Record last verified: 2010-04

Locations

ME (1)