NCT03057821

Brief Summary

The investigator's plan to determine whether pre-operative skin preparation with hydrogen peroxide alters rates of P acnes culture positivity. They hypothesize that pre-operative skin preparation with hydrogen peroxide will reduce rates of P acnes culture positivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

February 14, 2017

Last Update Submit

August 29, 2019

Conditions

Propionibacterium Acnes

Keywords

hydrogen peroxidePropionibacterium Acnesshoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Positive P acnes culture

    The primary outcome of the study will be P acnes culture positive results.

    2-weeks

Study Arms (2)

Control

NO INTERVENTION

The control group will not receive any hydrogen peroxide skin preparation

Treatment

EXPERIMENTAL

The treatment group will also undergo skin preparation with 3% hydrogen peroxide.

Other: 3% hydrogen peroxide

Interventions

3% hydrogen peroxideOTHER

The treatment group will also undergo skin preparation with 3% hydrogen peroxide.

Treatment

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing primary shoulder arthroplasty

You may not qualify if:

  • Patients with prior shoulder surgery.
  • Patients with a symptomatic infection or history of infection, recent antibiotic use (within six weeks), or with clinical signs of infection such as an elevated ESR, CRP, positive aspiration cultures, or positive biopsy.
  • Patients with a known hypersensitivity to hydrogen peroxide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Interventions

Hydrogen Peroxide

Intervention Hierarchy (Ancestors)

PeroxidesOxidesAnionsIonsElectrolytesInorganic ChemicalsReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic Chemicals

Study Officials

  • Peter Chalmers, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 20, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)