A Comparison of Infection Rates Between Two Surgical Sites

This study is currently recruiting participants.
Verified May 2012 by Mayo Clinic
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: March 18, 2013
Last verified: May 2012

December 16, 2010
March 18, 2013
January 2011
September 2013   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01263262 on ClinicalTrials.gov Archive Site
Infection rates [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
compare the infections rates between two institutions with different skin prep practices
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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?

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Corneal Toxicity
  • Ototoxicity
  • Surgical Site Infection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Not Provided
United States
 
NCT01263262
10-004643
No
Jerry Brewer, Mayo Clinic
Mayo Clinic
University of Toronto
Principal Investigator: Jerry Brewer, MD Mayo Clinic
Mayo Clinic
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP