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Surgical Prep in Hand Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01676051
First Posted: August 30, 2012
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Fowler, University of Pittsburgh
  Purpose
The purposes of this study are to identify the common bacterial flora on the hand and evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation. The null hypothesis is that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in pre-operative skin preparation in clean, elective hand surgery cases.

Condition Intervention
Surgical Scrubbing Disinfection Other: Skin culture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Surgical Preparation Solutions in Hand Surgery

Further study details as provided by John Fowler, University of Pittsburgh:

Primary Outcome Measures:
  • Number of positive cultures [ Time Frame: after skin prep solution has dried ]

Enrollment: 240
Study Start Date: December 2012
Study Completion Date: October 2017
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chloraprep Other: Skin culture
Culture swab used to culture skin adjacent to incision
Duraprep Other: Skin culture
Culture swab used to culture skin adjacent to incision
Betadine only Other: Skin culture
Culture swab used to culture skin adjacent to incision

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients undergoing clean, elective hand surgery without implants
Criteria

Inclusion Criteria:

  • the following procedures (carpal tunnel release, trigger finger release, cyst excision, 1st dorsal compartment release)

Exclusion Criteria:

  • prisoners
  • pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676051


Locations
United States, Pennsylvania
Montefiore Hospital
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: John Fowler, MD University of Pittsburgh