Comparison of Iodine + Isopropyl Alcohol Versus Iodine + Antimicrobial Sealant for Skin Preparation
Recruitment status was: Recruiting
|Surgical Site Infection||Device: 2-octyl cyanoacrylate [InteguSEAL®] Device: Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]||Phase 4|
|Study Design:||Allocation: Randomized
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|
- 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.
- 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.
|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)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110772
|Contact: Diana Vilar-Compte, MD, MsC||+52 555 628 0400 ext email@example.com|
|National Institute of Cancerology||Recruiting|
|Mexico City, DF, Mexico, 14080|
|Contact: Diana Vilar-Compte, MD, MsC +52 555 628 0400 ext 262 firstname.lastname@example.org|
|Principal Investigator:||Diana Vilar-Compte, MD;MsC||Instituto Nacional de Cancerologia, Columbia|