RECRUITING

Wound Irrigation Comparative Effectiveness Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.

Official Title

Cutibacterium Acnes Removal by Wound Irrigation With Normal Saline Versus Irrisept During Total Shoulder Arthroplasty

Quick Facts

Study Start:2024-03-20
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06379919

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Age younger than 18 years
  2. * History of shoulder infection
  3. * Antibiotic therapy within 2 weeks of surgery
  4. * Cortisone infiltration within 3 months prior to surgery
  5. * Allergy to CHG
  6. * Diagnosis of rheumatoid arthritis
  7. * Immunocompromised patients

Contacts and Locations

Study Contact

Vance Gardner, MD
CONTACT
(949) 526-1570
anabaino77@gmail.com

Principal Investigator

Hafiz F Kassam, MD
PRINCIPAL_INVESTIGATOR
Hoag Orthopedics Education and Research

Study Locations (Sites)

Hoag Orthopedics
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

  • Hafiz F Kassam, MD, PRINCIPAL_INVESTIGATOR, Hoag Orthopedics Education and Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-20
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2024-03-20
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cutibacterium Acnes Contamination