Study on the Reapplication of Chloraprep After Lower Extremity Surgery and Prior to Dressing Application

Surgical Site Infection Clinical Trial

Official title:

Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02017145
• Other study ID #: SH Chloraprep reapplication
• Status: Unknown status
• Phase: Phase 4
• First received: December 16, 2013
• Last updated: February 17, 2014
• Start date: February 2014

Study information

• Verified date: February 2014
• Source: Sanford Health
• Contact: Jeremy P Morgan, MS
• Phone: 605-328-1398
• Email: jeremy.morgan[@]sanfordhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding the surgical site during the initial healing phases would theoretically decrease the rate of infection in high-risk persons.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 140
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female

• Adults (18+)

• Both elective and non-elective procedures

• Lower extremity surgery performed below the knee and requiring post-operative splint immobilization for 2-3 weeks

• Able to understand and read the English language

• Signed informed consent

Exclusion Criteria:

• Pregnant (to be assessed the day of surgery per standard of care surgical protocol)

• Known allergies to chlorhexidine gluconate or isopropyl alcohol

• Multiple planned lower extremity surgeries

• Local skin disease

• Pre-existing or known infection at surgical site

• Open wounds or local abrasions

• Unable to or unwilling to follow through with study requirements

Related Conditions & MeSH terms

• Bacterial Colonization
• Lower Extremity Surgery
• Surgical Antiseptic
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Chloraprep

Locations

Country	Name	City	State
United States	Sanford USD Medical Center	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988. — View Citation

Gould D. Causes, prevention and management of surgical site infection. Nurs Stand. 2012 Jul 25-31;26(47):47-56; quiz 58. — View Citation

Hibbard JS, Mulberry GK, Brady AR. A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine. J Infus Nurs. 2002 Jul-Aug;25(4):244-9. — View Citation

Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005 May-Jun;28(3):194-207. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantitative bacterial colonization	Compare the number of colony forming units taken from culture swabs immediately adjacent to the wound during dressing change between the two arms	14-21 days
Primary	positive culture rate	Compare the overall positive culture rate between the two treatment groups	14-21 days
Secondary	bacterial strain identification	Assess the total number of bacterial strains and identifying those strains cultured from swabs taken immediately adjacent to the wound during dressing change	14-21 days