Surgical Prep in Hand Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
John Fowler, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01676051
First received: August 23, 2012
Last updated: May 12, 2014
Last verified: May 2014
  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 University of Pittsburgh:

Primary Outcome Measures:
  • Number of positive cultures [ Time Frame: after skin prep solution has dried ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: December 2012
Estimated 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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676051

Contacts
Contact: John Fowler, MD fowlerjr@upmc.edu

Locations
United States, Pennsylvania
Montefiore Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: John Fowler         
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: John R Fowler, MD         
Sub-Investigator: Robert Goitz, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: John Fowler, MD University of Pittsburgh
  More Information