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

Phase 4

Terminated

• Conditions: Arm Fracture; Surgical Site Infection
• Interventions: Other: Chlorhexidine; Other: Betadine

• Registration Number: NCT04225065
• Lead Sponsor: Mark Seeley

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.

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-06-17
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine prep	Chlorhexidine	Chlorhexidine prep prior to their operation
Betadine prep	Betadine	Betadine prep prior to their operation

Primary Outcome Measures

Name	Time	Method
Type and number of organisms found in culture	1 day	Type and number of organisms found in fingernail culture

Trial Locations

Locations (1)

Geisinger Woodbine; 🇺🇸 Danville, Pennsylvania, United States