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

NCT04225065 | Terminated

• 1 other identifier: 2019-0106
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Arm Fracture; Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Type and number of organisms found in culture

  Type and number of organisms found in fingernail culture

  1 day

Study Arms (2)

Chlorhexidine prep

ACTIVE COMPARATOR

Chlorhexidine prep prior to their operation

Other: Chlorhexidine

Betadine prep

ACTIVE COMPARATOR

Betadine prep prior to their operation

Other: Betadine

Interventions

Chlorhexidine OTHER

Chlorhexidine prep prior to surgery

Chlorhexidine prep

Betadine OTHER

Betadine prep prior to surgery

Betadine prep

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Patient with known immunodeficiency disorder

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Woodbine

Danville, Pennsylvania, 17821, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Chlorhexidine; Povidone-Iodine

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mark Seeley, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: June 17, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

US (1)