A Comparison of Infection Rates Between Two Surgical Sites
| Tracking Information | |||||
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| First Received Date ICMJE | December 16, 2010 | ||||
| Last Updated Date | March 18, 2013 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01263262 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Comparison of Infection Rates Between Two Surgical Sites | ||||
| Official Title ICMJE | 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 | ||||
| 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? |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01263262 | ||||
| Other Study ID Numbers ICMJE | 10-004643 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jerry Brewer, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | University of Toronto | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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