Corneal ToxicityNCT01263262
A Comparison of Infection Rates Between Two Surgical Sites
An observational study of Corneal Toxicity and Ototoxicity, run by Mayo Clinic at 1 site in United States.
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? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Toxicity, Ototoxicity, Surgical Site Infection
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing an outpatient cutaneous surgical procedure on the face.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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.
- Conditions
- Corneal Toxicity, Ototoxicity, Surgical Site Infection
- Keywords
- Surgical site infection, Corneal toxicity, Ototoxicity, Povidone-iodine, Chlorhexidine-alcohol
- Medical subject headings
- Ototoxicity, Surgical Wound Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular and Ear Toxicities
Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.
Measured: 1 year
Secondary outcomes (1)
Infection rates
compare the infections rates between two institutions with different skin prep practices
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal ToxicityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Jerry Brewer, Mayo Clinic
- Investigators
- Jerry Brewer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263262
- Sponsor's protocol ID
- 10-004643
- Status last verified
- Sep 2013
- First submitted
- 16 Dec 2010
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01263262
- Acronym / sponsor ID
- 10-004643
- Conditions
- Corneal Toxicity, Ototoxicity, Surgical Site Infection
- Keywords
- Surgical site infection, Corneal toxicity, Ototoxicity, Povidone-iodine, Chlorhexidine-alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Jan 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing an outpatient cutaneous surgical procedure on the face.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ocular and Ear Toxicities
Time frame: 1 year
Comparing ocular and ear toxicities between two institutions with differences in aseptic technique.
1 secondary outcome
Infection rates
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Brewer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Toxicity and Ototoxicity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular and Ear Toxicities (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2013.