Study on the Reapplication of Chloraprep After Lower Extremity Surgery and Prior to Dressing Application
Primary Purpose
Lower Extremity Surgery, Surgical Site Infection, Bacterial Colonization
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chloraprep
Sponsored by
About this trial
This is an interventional prevention trial for Lower Extremity Surgery focused on measuring infection, chloraprep, chlorhexidine, lower extremity surgery, antiseptic, bacterial colonization
Eligibility Criteria
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
Sites / Locations
- Sanford USD Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
no reapplication
reapplication
Arm Description
This group will not have chloraprep reapplied after their surgery and prior to dressing application.
This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.
Outcomes
Primary Outcome Measures
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
positive culture rate
Compare the overall positive culture rate between the two treatment groups
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02017145
Brief Title
Study on the Reapplication of Chloraprep After Lower Extremity Surgery and Prior to Dressing Application
Official Title
Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanford Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Surgery, Surgical Site Infection, Bacterial Colonization, Surgical Antiseptic
Keywords
infection, chloraprep, chlorhexidine, lower extremity surgery, antiseptic, bacterial colonization
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
no reapplication
Arm Type
No Intervention
Arm Description
This group will not have chloraprep reapplied after their surgery and prior to dressing application.
Arm Title
reapplication
Arm Type
Experimental
Arm Description
This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.
Intervention Type
Drug
Intervention Name(s)
Chloraprep
Primary Outcome Measure Information:
Title
quantitative bacterial colonization
Description
Compare the number of colony forming units taken from culture swabs immediately adjacent to the wound during dressing change between the two arms
Time Frame
14-21 days
Title
positive culture rate
Description
Compare the overall positive culture rate between the two treatment groups
Time Frame
14-21 days
Secondary Outcome Measure Information:
Title
bacterial strain identification
Description
Assess the total number of bacterial strains and identifying those strains cultured from swabs taken immediately adjacent to the wound during dressing change
Time Frame
14-21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy P Morgan, MS
Phone
605-328-1398
Email
jeremy.morgan@sanfordhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Hahn
Phone
605-328-1361
Email
diane.hahn@sanfordhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle T Judd, MD
Organizational Affiliation
Sanford Orthopedics and Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle T Judd, MD
Phone
605-328-2663
Email
kyle.judd@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Kyle T Judd, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22913092
Citation
Gould D. Causes, prevention and management of surgical site infection. Nurs Stand. 2012 Jul 25-31;26(47):47-56; quiz 58. doi: 10.7748/ns2012.07.26.47.47.c9226.
Results Reference
background
PubMed Identifier
15866959
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. doi: 10.2106/JBJS.D.01977.
Results Reference
background
PubMed Identifier
20054046
Citation
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.
Results Reference
background
PubMed Identifier
15912075
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. doi: 10.1097/00129804-200505000-00008.
Results Reference
background
PubMed Identifier
12131506
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. doi: 10.1097/00129804-200207000-00007.
Results Reference
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Study on the Reapplication of Chloraprep After Lower Extremity Surgery and Prior to Dressing Application
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