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Trial record 43 of 137 for:    acne AND peroxide

Does the Addition of Hydrogen Peroxide to Chlorhexidine Skin Prep to Treat P. Acnes in the Shoulder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656588
Recruitment Status : Enrolling by invitation
First Posted : September 4, 2018
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE August 23, 2018
First Posted Date  ICMJE September 4, 2018
Last Update Posted Date September 4, 2018
Actual Study Start Date  ICMJE April 16, 2018
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2018)
colonization of p.acnes in the dermis of the shoulder [ Time Frame: 14 days in culture ]
number of colony forming units grown in bacterial culture
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does the Addition of Hydrogen Peroxide to Chlorhexidine Skin Prep to Treat P. Acnes in the Shoulder
Official Title  ICMJE Does the Addition of Hydrogen Peroxide to Chlorhexidine Preoperative Skin Preparation Reduce the Rate of Propionibacterium Acnes Positive Culture in the Shoulder
Brief Summary This is a prospective, randomized controlled trial to evaluate the ability of hydrogen peroxide preparation in addition to chlorhexidine to decrease the colonization of Propionibacterium acnes(a bacteria commonly found in the dermis of the skin surrounding the shoulder in order to decrease postoperative joint infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Propionibacterium Infection
Intervention  ICMJE
  • Drug: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol
    a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol
  • Drug: Iodine scrub and ChloraPrep alone
    Iodine scrub and ChloraPrep alone
Study Arms  ICMJE
  • Active Comparator: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by
    Intervention: Drug: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol
  • Active Comparator: b. Iodine scrub and ChloraPrep alone
    Intervention: Drug: Iodine scrub and ChloraPrep alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Actual Enrollment  ICMJE
 (submitted: August 31, 2018)
100
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. All male patients (>18) undergoing shoulder arthroscopy

Exclusion Criteria:

  1. Female patients
  2. Patients with active acne
  3. Patients who have taken antibiotics within a month of their surgery
  4. Subjects allergic to any of the following agents:

    o Benzoyl peroxide

  5. Subjects with psoriatic/eczematous lesions on the shoulder girdle.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03656588
Other Study ID Numbers  ICMJE 2018SNam2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rothman Institute Orthopaedics
Study Sponsor  ICMJE Rothman Institute Orthopaedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP