A Comparison of Infection Rates Between Two Surgical Sites

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Corneal Toxicity Ototoxicity Surgical Site Infection

Keywords

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Surgical site infection Corneal toxicity Ototoxicity Povidone-iodine Chlorhexidine-alcohol

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Jerry Brewer

Associate Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerry Brewer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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10-004643

Identifier Type: -

Identifier Source: org_study_id