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A Comparison of Infection Rates Between Two Surgical Sites

This study has been completed.
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Jerry Brewer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01263262
First received: December 16, 2010
Last updated: October 23, 2013
Last verified: September 2013
  Purpose

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
Corneal Toxicity
Ototoxicity
Surgical Site Infection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Ocular and Ear Toxicities [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.


Secondary Outcome Measures:
  • Infection rates [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    compare the infections rates between two institutions with different skin prep practices


Enrollment: 600
Study Start Date: January 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263262

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Toronto
Investigators
Principal Investigator: Jerry Brewer, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Jerry Brewer, Associate Professor of Dermatology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01263262     History of Changes
Other Study ID Numbers: 10-004643
Study First Received: December 16, 2010
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Surgical site infection
Corneal toxicity
Ototoxicity
Povidone-iodine
Chlorhexidine-alcohol

Additional relevant MeSH terms:
Communicable Diseases
Infection
Chlorhexidine
Povidone-Iodine
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014