A Comparison of Infection Rates Between Two Surgical Sites

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01263262

Collaborator

University of Toronto (Other)

600

Enrollment

Location

Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Corneal Toxicity Ototoxicity Surgical Site 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 Design

Study Type:

Observational

Actual Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Outcome Measures

Primary Outcome Measures

Ocular and Ear Toxicities [1 year]
Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.

Secondary Outcome Measures

Infection rates [1 year]
compare the infections rates between two institutions with different skin prep practices

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.