A Comparison of Infection Rates Between Two Surgical Sites

NCT01263262 | Completed

• 1 other identifier: 10-004643
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Corneal Toxicity; Ototoxicity; Surgical Site Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ocular and Ear Toxicities

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

  1 year

Secondary Outcomes (1)

• Infection rates

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Toronto: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Ototoxicity; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Wound Infection; Infections; Postoperative Complications

Study Officials

• Jerry Brewer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 20, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 24, 2013

Record last verified: 2013-09

Locations

US (1)