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Skin Preparation for Elective Foot and Ankle Surgery

Primary Purpose

Microbial Colonization, Foot and Ankle Disorders

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hibiclens
Isopropyl Alcohol 70% Topical Application Solution
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Microbial Colonization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing elective foot and ankle surgeries
  • age over 18

Exclusion Criteria:

  • trauma as the indication for surgery
  • open injuries
  • non-elective procedures
  • amputations
  • prior surgical site infection through the planned incision
  • pregnancy. All potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to SOC surgical procedure.

Sites / Locations

  • University of MissouriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Iodine or Chlorhexidine Preparation

Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap

Arm Description

Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery.

In addition to standard of care skin preparation with iodine or chlorhexidine solution prior to sterile draping, patients will also receive an additional "pre-scrub" with isopropyl alcohol and chlorhexidine soap. The operative extremity will be scrubbed for 2 minutes with chlorhexidine soap with a scrub brush until the entire extremity is covered. Isopropyl alcohol will then be wiped onto the skin with a gauze and allowed to evaporate (dry).

Outcomes

Primary Outcome Measures

Surgical Site Infection
rate of surgical site infection (SSI) and wound complications following skin preparation for surgery. Measured by the number of surgical site infections in the total population of patients in the cohort

Secondary Outcome Measures

Microbial Load
effectiveness of reducing microbial load. Comparing original microbial load to final microbial load (CFU/g)

Full Information

First Posted
February 23, 2022
Last Updated
July 27, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05401292
Brief Title
Skin Preparation for Elective Foot and Ankle Surgery
Official Title
Skin Preparation for Elective Foot and Ankle Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Surgical site infections (SSIs) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. For foot and ankle elective interventions, SSI rate is reported between 0.4% and 3.6%. This study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. Current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. Standard of care will be applied to all patients. The use of an additional "pre-scrub" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. The control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization, Foot and Ankle Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iodine or Chlorhexidine Preparation
Arm Type
Active Comparator
Arm Description
Standard of care with only skin preparation of iodine or chlorhexidine solution prior to sterile draping before surgery.
Arm Title
Iodine or Chlorhexidine Scrub Brush Pre-Scrub with Isopropyl Alcohol and Chlorhexidine Soap
Arm Type
Active Comparator
Arm Description
In addition to standard of care skin preparation with iodine or chlorhexidine solution prior to sterile draping, patients will also receive an additional "pre-scrub" with isopropyl alcohol and chlorhexidine soap. The operative extremity will be scrubbed for 2 minutes with chlorhexidine soap with a scrub brush until the entire extremity is covered. Isopropyl alcohol will then be wiped onto the skin with a gauze and allowed to evaporate (dry).
Intervention Type
Drug
Intervention Name(s)
Hibiclens
Intervention Description
antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing
Intervention Type
Drug
Intervention Name(s)
Isopropyl Alcohol 70% Topical Application Solution
Intervention Description
First aid antiseptic
Primary Outcome Measure Information:
Title
Surgical Site Infection
Description
rate of surgical site infection (SSI) and wound complications following skin preparation for surgery. Measured by the number of surgical site infections in the total population of patients in the cohort
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Microbial Load
Description
effectiveness of reducing microbial load. Comparing original microbial load to final microbial load (CFU/g)
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing elective foot and ankle surgeries age over 18 Exclusion Criteria: trauma as the indication for surgery open injuries non-elective procedures amputations prior surgical site infection through the planned incision pregnancy. All potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to SOC surgical procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacee Baker, MEd, BSN, RN
Phone
5738849017
Email
staceebaker@health.missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kyle Schweser, MD
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacee Baker, MEd, BSN, RN
Phone
573-884-9017
Email
staceebaker@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Kyle Schweser, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Skin Preparation for Elective Foot and Ankle Surgery

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