Decreasing Infection In Arthroscopic Shoulder Surgery

NCT02219776 | Completed

• 1 other identifier: 201400113
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the use of a standard preoperative skin disinfectant prior to shoulder surgery propionibacterium acne remains a leading cause of post-operative infections. The purpose of this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to chlorhexidine-impregnated skin preparation in attempting to lower the colonization propionibacterium acne prior to surgery. This study will take cultures from patients who are randomly assigned into groups that receive and do not receive benzoyl peroxide as additional skin prep prior to elective shoulder surgery and compare quantified culture results.

Conditions

Post Operative Infection Arthroscopic Shoulder Surgery; Infection

Keywords

Infection,; Proprionbacterium Acne,; Shoulder,; skin preparation

Outcome Measures

Primary Outcomes (1)

• Bacterial Growth

  Skin swabs and biopsy will be cultured for 14 days in media specific for growing P.Acne

  14 days from culture

Study Arms (2)

Chlorhexidine Standard of Care Arm

ACTIVE COMPARATOR

Use of Chlorhexidine to cleanse pre-operative surgery site

Other: Standard of Care - Chlorhexidine Scrub only

Benzoyl Peroxide Experimental Arm

EXPERIMENTAL

Use of Chlorhexidine scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient

Drug: Benzoyl Peroxide solution Plus Chlorhexidine Scrub

Interventions

Benzoyl Peroxide solution Plus Chlorhexidine Scrub DRUG

Subjects will be provided instructions on how to use and apply the chlorhexidine using a scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient application

Benzoyl Peroxide Experimental Arm

Standard of Care - Chlorhexidine Scrub only OTHER

Subjects will be given instructions on how to apply the Chlorhexidine using a scrub brush

Chlorhexidine Standard of Care Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective arthroscopic shoulder surgery
• Ages \> 18
• Male and Female

You may not qualify if:

• Active Infection
• History of ipsilateral prior shoulder surgery
• History of prior shoulder infection
• Current use of Antibiotics
• History of immunosuppression
• Open wounds
• History of Inflammatory arthritis
• Allergy to benzoyl peroxide
• Allergy to chlorhexidine

Sponsors & Collaborators

• McLaren Health Care: lead

Study Sites (1)

McLaren Greater Lansing

Lansing, Michigan, 28910, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

• Landon R Fine, DO

  McLaren Greater Lansing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2014
• First Posted: August 19, 2014
• Study Start: September 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

US (1)