Clinical trial NCT01263262: A Comparison of Infection Rates Between Two Surgical Sites
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Toxicity
Ototoxicity
Surgical Site Infection
Keywords: Surgical site infection
Corneal toxicity
Ototoxicity
Povidone-iodine
Chlorhexidine-alcohol
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2010-12-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ocular and Ear Toxicities
timeFrame: 1 year
Secondary outcomes:
measure: Infection rates
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jerry Brewer, MD
role: PRINCIPAL_INVESTIGATOR
References: