NCT01676051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

August 23, 2012

Last Update Submit

October 28, 2017

Conditions

Surgical ScrubbingDisinfection

Outcome Measures

Primary Outcomes (1)

  • Number of positive cultures

    after skin prep solution has dried

Study Arms (3)

Chloraprep

Other: Skin culture

Duraprep

Other: Skin culture

Betadine only

Other: Skin culture

Interventions

Skin cultureOTHER

Culture swab used to culture skin adjacent to incision

Betadine onlyChloraprepDuraprep

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients undergoing clean, elective hand surgery without implants

You may qualify if:

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

You may not qualify if:

  • prisoners
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

  • 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.

    PMID: 22437997BACKGROUND

  • 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.

    PMID: 19651954BACKGROUND

  • 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.

    PMID: 15866959BACKGROUND

Study Officials

  • John Fowler, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 30, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

October 1, 2017

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

US(2)