Clinical trial

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

Name
2019-0106
Description
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.
Trial arms
Trial start
2020-06-17
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Terminated
Phase
Early phase I
Treatment
Chlorhexidine
Chlorhexidine prep prior to surgery
Arms:
Chlorhexidine prep
Betadine
Betadine prep prior to surgery
Arms:
Betadine prep
Size
10
Primary endpoint
Type and number of organisms found in culture
1 day
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}
Updated at
2024-05-01

1 organization

2 products

2 indications

Organization
Mark Seeley
Indication
Fracture
Indication
SSIs
Product
Betadine