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Surgical Prep in Hand Surgery

NCT ID: NCT01676051

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Scrubbing Disinfection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chloraprep

Skin culture

Intervention Type OTHER

Culture swab used to culture skin adjacent to incision

Duraprep

Skin culture

Intervention Type OTHER

Culture swab used to culture skin adjacent to incision

Betadine only

Skin culture

Intervention Type OTHER

Culture swab used to culture skin adjacent to incision

Interventions

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Skin culture

Culture swab used to culture skin adjacent to incision

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* prisoners
* pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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John Fowler

Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Montefiore Hospital

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22437997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19651954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15866959 (View on PubMed)

Other Identifiers

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PRO12080340

Identifier Type: -

Identifier Source: org_study_id