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

Surgical Site Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01110772
• Other study ID #: 09003INI
• Status: Recruiting
• Phase: Phase 4
• First received: April 23, 2010
• Last updated: April 26, 2010
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: National Institute of Cancerología
• Contact: Diana Vilar-Compte, MD, MsC
• Phone: +52 555 628 0400
• Email: parakalomx[@]yahoo.com.mx
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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).
• 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.

Locations

Country	Name	City	State
Mexico	National Institute of Cancerology	Mexico City	DF

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Cancerología	Kimberly-Clark de México

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cost analysis	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.	30-45 days	No