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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01263262

Enrollment

600

Registered

2010-12-20

Start date

2011-01-31

Completion date

2013-08-31

Last updated

2013-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Toxicity, Ototoxicity, Surgical Site Infection

Keywords

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

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?

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Ocular and Ear Toxicities	1 year	Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.

Secondary

Measure	Time frame	Description
Infection rates	1 year	compare the infections rates between two institutions with different skin prep practices

Countries

United States

Outcome results