A Comparison of Infection Rates Between Two Surgical Sites

Surgical Site Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263262
• Other study ID #: 10-004643
• Status: Completed
• Phase: N/A
• First received: December 16, 2010
• Last updated: October 23, 2013
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Corneal Toxicity
• Infection
• Ototoxicity
• Surgical Site Infection
• Surgical Wound Infection

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	University of Toronto

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular and Ear Toxicities	Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.	1 year	Yes
Secondary	Infection rates	compare the infections rates between two institutions with different skin prep practices	1 year	Yes