Clinical Trials

A Comparison of Infection Rates Between Two Surgical Sites

Location:

Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria:

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

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.

Last updated: 03/18/2013

NCT ID: NCT01263262

IRB Number:10-004643