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CompletedNCT01676051Updated Oct 31, 2017

Surgical Prep in Hand Surgery

An observational study in Surgical Scrubbing and Disinfection, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Surgical Scrubbing
  • Disinfection
03

In context

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Browse University of Pittsburgh studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients undergoing clean, elective hand surgery without implants

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • prisoners
  • pregnant women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (actual)

Groups and cohorts

  • Chloraprep

    Other: Skin culture

  • Duraprep

    Other: Skin culture

  • Betadine only

    Other: Skin culture

Interventions

  • OtherSkin culture

    Culture swab used to culture skin adjacent to incision

06

What researchers measure

Primary outcomes

  1. Number of positive cultures

    Time frame: after skin prep solution has dried

07

Study locations

2 sites
  • Montefiore Hospital
    Pittsburgh, Pennsylvania 15213, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Publications

  • Savage JW, Weatherford BM, Sugrue PA, Nolden MT, Liu JC, Song JK, Haak MH. Efficacy of surgical preparation solutions in lumbar spine surgery. J Bone Joint Surg Am. 2012 Mar 21;94(6):490-4. doi: 10.2106/JBJS.K.00471. PubMed 22437997 ↗
  • Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768. PubMed 19651954 ↗
  • Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977. PubMed 15866959 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2012, a primary completion of Dec 2014 and a completion of Oct 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2012
First posted
Aug 30, 2012
Start
Dec 2012
Primary completionActual
Dec 2014
CompletionActual
Oct 2017
Last update
Oct 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01676051
Lead sponsor
University of Pittsburgh
Responsible party
John Fowler (Fellow, University of Pittsburgh) — Principal investigator
First posted
Aug 30, 2012
Start date
Dec 2012
Primary completion
Dec 2014
Completion
Oct 2017
Last update
Oct 31, 2017

Study contacts

John Fowler, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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