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Chlorhexidine and/or Betadine Prep in Pediatric Arm Surgery Following Trauma

Primary Purpose

Arm Fracture, Surgical Site Infection

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine
Betadine
Sponsored by
Mark Seeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arm Fracture

Eligibility Criteria

undefined - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient less than or equal to 10 years of age
  • Undergoing wrist, forearm, or elbow internal fixation surgery

Exclusion Criteria:

  • Patient with known immunodeficiency disorder

Sites / Locations

  • Geisinger WoodbineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Chlorhexidine prep

Betadine prep

Arm Description

Chlorhexidine prep prior to their operation

Betadine prep prior to their operation

Outcomes

Primary Outcome Measures

Type and number of organisms found in culture
Type and number of organisms found in fingernail culture

Secondary Outcome Measures

Full Information

First Posted
January 8, 2020
Last Updated
March 17, 2023
Sponsor
Mark Seeley
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1. Study Identification

Unique Protocol Identification Number
NCT04225065
Brief Title
Chlorhexidine and/or Betadine Prep in Pediatric Arm Surgery Following Trauma
Official Title
Does Chlorhexidine and/or Betadine Prep Thoroughly Clean the Surgical Sites and Fingernails in Pediatric Arm Surgery Following Trauma?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Seeley

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.
Yes

5. Study Description

Brief Summary
There have been numerous studies demonstrating surgical site infections that arise from contamination at time of surgery or by seeding from other sites in the body which arise from organisms normally found on the skin. This has been known to cause complications in spine surgery, shoulder, hip, and knee arthroplasty. While studies have shown that organisms like Cutibacterium persists on the skin despite standard surgical preparation, there have not been studies that examine the organisms found in the fingernail region pre- and post- standard surgical preparations. This study investigates how thorough fingernails are prepped prior to the operation. The results of this study would determine whether providers are adequately cleaning the patient's entire arm, including under the fingernail, prior to surgery. The results may support continuation of the current practice or adding to the standard surgical preparation to ensure adequately sterilization of surgical sites and all exposed areas, which include the fingernails.
Detailed Description
It is well known that even with surgical skin preparation, there are some microorganisms that remain on the patient's skin. There have been numerous studies demonstrating surgical site infections that arise from contamination at time of surgery or by seeding from other sites in the body which arise from organisms normally found on the skin. This has been known to cause complications in spine surgery, shoulder, hip, and knee arthroplasty. While studies have shown that organisms like Cutibacterium persist on the skin despite standard surgical preparation, there have not been studies that examine the organisms found in the fingernail region pre- and post- standard surgical preparations. It is common practice to not cover the fingernails when patients are undergoing distal upper extremity surgery. Providers tend to consider them prepped when they have the chlorhexidine or betadine preparations applied; however, there is uncertainty regarding how much attention is given to the fingernails. This study investigates how thorough fingernails are prepped prior to the operation. The results of this study would determine whether providers are adequately cleaning the patient's entire arm, including under the fingernail, prior to surgery. The results may support continuation of the current practice or adding to the standard surgical preparation to ensure adequate sterilization of surgical sites and all exposed areas, which include the fingernails. This is a prospective study design of 20 pediatric patients who are undergoing distal upper extremity surgery. Ten patients will receive a chlorhexidine prep prior to their operation, and the other 10 will receive a betadine prep. Patients will be considered for the study if they are 10 years old or younger and are having either wrist, forearm, or elbow internal fixation surgeries. Three culture specimens will be sent to microbiology: 1) before the surgical skin preparation; 2) after the skin preparation but before the operation; and 3) after the operation. Culture results will be compared pre- and post- surgical prep and between chlorhexidine and betadine preps.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arm Fracture, Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine prep
Arm Type
Active Comparator
Arm Description
Chlorhexidine prep prior to their operation
Arm Title
Betadine prep
Arm Type
Active Comparator
Arm Description
Betadine prep prior to their operation
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Description
Chlorhexidine prep prior to surgery
Intervention Type
Drug
Intervention Name(s)
Betadine
Intervention Description
Betadine prep prior to surgery
Primary Outcome Measure Information:
Title
Type and number of organisms found in culture
Description
Type and number of organisms found in fingernail culture
Time Frame
1 day

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient less than or equal to 10 years of age Undergoing wrist, forearm, or elbow internal fixation surgery Exclusion Criteria: Patient with known immunodeficiency disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Seeley, MD
Phone
570-214-4806
Email
mseeley1@geisinger.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Sams
Phone
570-214-6178
Email
kbsams@geisinger.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Seeley, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Woodbine
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Sams
Phone
570-214-6178
Email
MSKIresearch@geisinger.edu

12. IPD Sharing Statement

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Chlorhexidine and/or Betadine Prep in Pediatric Arm Surgery Following Trauma

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