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

Does Chlorhexidine and/or Betadine Prep Thoroughly Clean the Surgical Sites and Fingernails in Pediatric Arm Surgery Following Trauma?

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infection; Arm Fracture
• Intervention / Treatment: Drug: Chlorhexidine; Drug: Betadine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mark Seeley, MD; Phone Number: 570-214-4806; Email: mseeley1@geisinger.edu

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17821
      • Recruiting
      • Geisinger Woodbine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chlorhexidine prep; Chlorhexidine prep prior to their operation	Drug: Chlorhexidine; Chlorhexidine prep prior to surgery
Active Comparator: Betadine prep; Betadine prep prior to their operation	Drug: Betadine; Betadine prep prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type and number of organisms found in culture	Type and number of organisms found in fingernail culture	1 day

Collaborators and Investigators

• Sponsor: Mark Seeley
• Investigators: Principal Investigator: Mark Seeley, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine; Povidone-Iodine
• Other Study ID Numbers: 2019-0106

Drug and device information, study documents

• 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