NCT03656588

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 16, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

August 23, 2018

Last Update Submit

August 31, 2018

Conditions

Propionibacterium Infection

Outcome Measures

Primary Outcomes (1)

  • colonization of p.acnes in the dermis of the shoulder

    number of colony forming units grown in bacterial culture

    14 days in culture

Study Arms (2)

a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by

ACTIVE COMPARATOR
Drug: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol

b. Iodine scrub and ChloraPrep alone

ACTIVE COMPARATOR
Drug: Iodine scrub and ChloraPrep alone

Interventions

a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcoholDRUG

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
Iodine scrub and ChloraPrep aloneDRUG

Iodine scrub and ChloraPrep alone

b. Iodine scrub and ChloraPrep alone

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. All male patients (\>18) undergoing shoulder arthroscopy

You may not qualify if:

  • Female patients
  • Patients with active acne
  • Patients who have taken antibiotics within a month of their surgery
  • Subjects allergic to any of the following agents:
  • o Benzoyl peroxide
  • Subjects with psoriatic/eczematous lesions on the shoulder girdle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate2-Propanol

Intervention Hierarchy (Ancestors)

PropanolsAlcoholsOrganic Chemicals

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

August 23, 2018

First Posted

September 4, 2018

Study Start

April 16, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

September 4, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)