CClinicalTrials.gg
CompletedNCT01263262Updated Oct 24, 2013

A Comparison of Infection Rates Between Two Surgical Sites

An observational study in Corneal Toxicity, Ototoxicity and Surgical Site Infection, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-24.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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?

Read the 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.

02

Conditions studied

  • Corneal Toxicity
  • Ototoxicity
  • Surgical Site Infection

Keywords

  • Surgical site infection
  • Corneal toxicity
  • Ototoxicity
  • Povidone-iodine
  • Chlorhexidine-alcohol
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

  • Patients undergoing an outpatient cutaneous surgical procedure on the face.

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (actual)
05

What researchers measure

Primary outcomes

  1. Ocular and Ear Toxicities

    Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.

    Time frame: 1 year

Secondary outcomes

  1. Infection rates

    compare the infections rates between two institutions with different skin prep practices

    Time frame: 1 year

06

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
07

Registry details

Key details

Study ID
NCT01263262
Lead sponsor
Mayo Clinic
Collaborators
University of Toronto
Responsible party
Jerry Brewer (Associate Professor of Dermatology, Mayo Clinic) — Principal investigator
First posted
Dec 20, 2010
Start date
Jan 2011
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Oct 24, 2013

Study contacts

Jerry Brewer, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion