Surgical Prep in Hand Surgery

Disinfection Clinical Trial

Official title:

Efficacy of Surgical Preparation Solutions in Hand Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676051
• Other study ID #: PRO12080340
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: October 28, 2017
• Start date: December 2012
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• prisoners

• pregnant women

Related Conditions & MeSH terms

• Disinfection
• Surgical Scrubbing

Intervention

Other:
• Skin culture
Culture swab used to culture skin adjacent to incision

Locations

Country	Name	City	State
United States	Montefiore Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of positive cultures		after skin prep solution has dried