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Surgical Prep in Hand Surgery

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ClinicalTrials.gov Identifier: NCT01676051
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
John Fowler, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment
Surgical Scrubbing Disinfection Other: Skin culture

Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Surgical Preparation Solutions in Hand Surgery
Study Start Date : December 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : October 2017

Group/Cohort Intervention/treatment
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



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


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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

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