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Skin Prep to Reduce Postoperative Shoulder Infection

Primary Purpose

Shoulder Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin Prep Chlorhexidine
Skin Prep Benzoyl Peroxide
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18
  • Indicated for shoulder surgery

Exclusion Criteria:

  • History of previous shoulder infection
  • Allergy to Chlorhexidine or benzoyl peroxide
  • Current use of anti-acne medicine around the shoulder
  • Patient is pregnant or concerned about pregnancy

Sites / Locations

  • University of Maryland Midtown Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chlorhexidine

Benzoyl Peroxide

Arm Description

A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens)

A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)

Outcomes

Primary Outcome Measures

Skin Swab and Culture With Colony Forming Units (CFUs)
Preoperative Cutibacterium acnes shoulder burden. Skin cultures of both shoulders were obtained via a detergent scrub technique the day of surgery at anterior, lateral, and posterior sites and the axilla.

Secondary Outcome Measures

Surgical Site Infection That Requires Antibiotics
Cultures were evaluated in our lab and also tested for hemolysis as a possible indicator of a more virulent strain in the literature.

Full Information

First Posted
July 23, 2015
Last Updated
January 29, 2020
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT02510144
Brief Title
Skin Prep to Reduce Postoperative Shoulder Infection
Official Title
Adjusting Skin Prep to Decrease Risk of P. Acnes Related Shoulder Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Propionibacterium acnes is the most common pathogen identified from a surgical site infection in the shoulder. Standard skin preps do not prevent this type of infection. Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery. Bacterial burden will be determined at the time of surgery.
Detailed Description
After surgical posting, patients will be randomized to chlorhexidine or benzoyl peroxide group. The solutions used will be 5% benzoyl peroxide emollient foam and 4% chlorhexidine gluconate skin cleanser. Participants will be instructed to conduct skin wash using the appropriate solution in the shower over the operative shoulder and axilla for three mornings prior to surgery (pre op day -2, pre op day -1, and morning of surgery). Specific instructions will include leaving the solution on the skin for three minutes and avoiding contact with eyes, ears, and mouth. Proper technique will be demonstrated at time of patient recruitment and given as a handout with the wash solution provided. A reminder phone call will occur two days before surgery to remind patients of proper procedure to improve compliance. On the day of surgery, patients be interviewed about pre-operative compliance. On the day of surgery, two cultures will be taken in three separate sites on both shoulders (anterior, lateral, and posterior) using a detergent scrub technique, the current dermatologic standard for biopsy of the deep sebaceous glands. (3,11) This procedure is typically performed on the skin of awake patients and causes minimal pain and skin irritation. Cultures will be evaluated in our lab. We will also test for hemolysis as a possible indicator of a more virulent strain in the literature. The research team may take photos of the shoulder skin being swabbed. Photos will not include the facial or defining characteristics. Photos may be taken either in the clinic at time of recruitment or in the operating room when samples are being taken. Inclusion criteria: all patients undergoing open shoulder surgery or shoulder arthroscopy. Exclusion criteria: anyone with a history of allergic reaction to chlorhexidine or benzoyl peroxide. Anyone with a history of previous shoulder infection, current open skin lesions around the shoulder or the use of current anti-acne medications around the shoulder. Healthy volunteer portion: Healthy volunteers will respond to the study from fliers on campus. A cotton swab test on both shoulders will be performed prior to any treatment. If a threshold of P. Acnes is met (>1000 Colony Forming Units (CFUs)) then volunteers will be randomized to the same two groups and retested after three days of unilateral treatment. Finally, volunteers will undergo repeat cotton swab testing one week after 3 day wash was finalized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens)
Arm Title
Benzoyl Peroxide
Arm Type
Experimental
Arm Description
A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)
Intervention Type
Drug
Intervention Name(s)
Skin Prep Chlorhexidine
Intervention Description
3 day preoperative skin prep prior to surgery
Intervention Type
Drug
Intervention Name(s)
Skin Prep Benzoyl Peroxide
Intervention Description
3 day preoperative skin prep prior to surgery
Primary Outcome Measure Information:
Title
Skin Swab and Culture With Colony Forming Units (CFUs)
Description
Preoperative Cutibacterium acnes shoulder burden. Skin cultures of both shoulders were obtained via a detergent scrub technique the day of surgery at anterior, lateral, and posterior sites and the axilla.
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Surgical Site Infection That Requires Antibiotics
Description
Cultures were evaluated in our lab and also tested for hemolysis as a possible indicator of a more virulent strain in the literature.
Time Frame
At one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 Indicated for shoulder surgery Exclusion Criteria: History of previous shoulder infection Allergy to Chlorhexidine or benzoyl peroxide Current use of anti-acne medicine around the shoulder Patient is pregnant or concerned about pregnancy
Facility Information:
Facility Name
University of Maryland Midtown Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Skin Prep to Reduce Postoperative Shoulder Infection

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