A Comparison of Infection Rates Between Two Surgical Sites

Completed

• Conditions: Corneal Toxicity; Ototoxicity; Surgical Site Infection

• Registration Number: NCT01263262
• Lead Sponsor: Mayo Clinic

Brief Summary

Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub on the face prior to cutaneous surgery decrease the chances of a post-operative wound infection?

Detailed Description

The intent of this proposed prospective observational cohort study is to determine if there is a difference in the incidence of corneal toxicity and/or ototoxicity in study subjects undergoing Mohs micrographic surgery (MMS) on the face if a povidone-iodine preparation is used pre-operatively as compared to a chlorhexidine-alcohol preparation. It has recently been found that the use of a chlorhexidine-alcohol preparation is superior to the use of a povidone-iodine preparation in preventing post-operative surgical-site infections (SSI) in patients undergoing clean-contaminated surgery. However, the use of chlorhexidine on the face has previously been associated with corneal toxicity and ototoxicity. This study will help to further define previously reported risks of corneal toxicity and ototoxicity associated with the use of a chlorhexidine solution on the face.

Study Timeline

• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-20
• Study Start: 2011-01
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients undergoing an outpatient cutaneous surgical procedure on the face.

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Exclusion Criteria

• Those who do not consent to participation
• Those undergoing cutaneous surgery for a lesion on the eyelid margin
• Patients with a history of ongoing eye pain
• History of a pre-existing corneal ulcer within 12 months prior to surgery
• History of a perforated tympanic membrane
• Patients with an active infection at the surgical site at the time of surgery.
• If post-operative follow-up is not completed, the study subject will be excluded from the analysis.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular and Ear Toxicities	1 year	Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.

Secondary Outcome Measures

Name	Time	Method
Infection rates	1 year	compare the infections rates between two institutions with different skin prep practices

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States