NCT00467857

Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination

A Randomized, Controlled, Parallel Group, Multi-center, Open Label Study Comparing Common Surgical Skin Preparation Solutions in Combination With InteguSeal Versus Common Surgical Skin Preparation Solutions to Reduce Skin Flora Contamination.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 293 (actual)
• Sponsor: Kimberly-Clark Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if there is a qualitative reduction in microbial skin flora post-surgery compared to pre-surgery when a cyanoacrylate based microbial sealant is used in combination with a surgical skin preparation solution.

Detailed description

The CDC states that there are two sources of surgical site infection (SSI) pathogens- endogenous and exogenous. The endogenous flora of the patient's skin, mucous membranes, or hollow viscera are the source of pathogens for most SSIs. In addition to the known sources of SSI pathogen, there are also known risk factors for SSI. The risk factors for SSIs may be patient-related, or related to the preoperative, intra-operative, and post-operative surgical treatment and care of the patient. Many known risk factors that contribute to SSIs include, but are not limited to age, nutritional status, co-morbidities, length of pre-operative stay, duration of operation, preoperative skin prep, and surgical techniques. In addition, there are certain surgical procedures in which the risks for developing SSI are greater than other surgical procedures. While there are various pre-operative and post-operative techniques or approaches to prevent these infections in patients undergoing surgeries, such as pre-operative skin care techniques, appropriate use of antibiotic prophylaxis, and the use of other post-operative anti-microbial methods, by immobilizing the patient's endogenous skin flora, an opportunity exists to reduce the rate of skin flora contamination which leads to wound contamination.

Conditions

• Skin Flora Contamination

Interventions

Type	Name	Description
PROCEDURE	InteguSeal* skin sealant and standard surgical preparation	Surgical skin preparation prior to incision using InteguSeal\* skin sealant following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
OTHER	Standard preoperative skin preparation	Surgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-05-01
• Last updated: 2012-09-18
• Results posted: 2011-02-11

Locations

5 sites across 5 countries: United States, Brazil, Chile, Germany, Singapore