A Comparison of Infection Rates Between Two Surgical Sites

A Comparative Assessment Between Two Surgical Sites of the Rate of Corneal Toxicity and Ototoxicity With the Use of Povidone-iodine Versus Chlorhexidine-alcohol for Facial Lesions Treated With Mohs Micrographic Surgery

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?

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; Ototoxicity; Corneal Toxicity

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients 18 years of age or older undergoing Mohs micrographic surgery for a skin neoplasm(s) on the face at the Dermatology Surgery Center at the Mayo Clinic in Rochester, Minnesota, and at the University of Toronto in Toronto, Ontario, Canada, will be included. Exclusion criteria will include: those undergoing MMS 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, and patients with an active infection at the operative site at the time of surgery. If post-operative follow-up is not completed, the study subject will be excluded from the study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular and Ear Toxicities	Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rates	compare the infections rates between two institutions with different skin prep practices	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: University of Toronto
• Investigators: Principal Investigator: Jerry Brewer, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 16, 2010
• First Submitted That Met QC Criteria: December 17, 2010
• First Posted (Estimate): December 20, 2010

Study Record Updates

• Last Update Posted (Estimate): October 24, 2013
• Last Update Submitted That Met QC Criteria: October 23, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Ototoxicity; Surgical site infection; Povidone-iodine; Corneal toxicity; Chlorhexidine-alcohol
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Postoperative Complications; Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Wound Infection; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Infections; Surgical Wound Infection; Ototoxicity
• Other Study ID Numbers: 10-004643