The Effect of Pretreatment for Propionibacterium Acnes on Surgical Site Burden in Shoulder Arthroplasty

NCT04112407 | Completed FDA Device

• 1 other identifier: 5316
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Cutibacterium acnes - formally known as Propionibacter acnes (P. acnes) is the most common pathogen associated with prosthetic joint infection of the shoulder. Despite current skin preparation techniques, P. acnes is encountered at the skin surface and at the natural reservoir in the sebaceous glands during the surgical exposure; current levels of exposure are implicated in overall prosthetic infection risk. Therefore, this study endeavors to decrease P. acnes burden at the surgical incision using preoperative blue light phototherapy and benzyl peroxide washes targeting both the skin surface and sebaceous glands.

Conditions

Shoulder Arthroplasty

Keywords

P. Acnes; shoulder arthroplasty; blue light therapy; benzoyl peroxide

Outcome Measures

Primary Outcomes (1)

• Rate of total culture positivity during shoulder arthroplasty

  To compare the rates of P. Acnes culture positivity (including all samples) between groups. Therein, assessing the efficacy of the interventions to decrease P. Acnes burden (measured by the rate of culture positivity) in surgical field.

  14 days in culture

Secondary Outcomes (1)

• Correlation of the rate of superficial culture positivity and the rate deep culture positivity during shoulder arthroplasty

  14 days in culture

Study Arms (3)

Control

EXPERIMENTAL

Standard preparation of the surgical site without P. acnes pretreatment

Other: Control

BPO Group

EXPERIMENTAL

Pretreatment with 10% Benzoyl peroxide body wash for two consecutive days of washes prior to surgery at home. The anterior shoulder area is wet before treatment; the wash is massaged in for 20 seconds producing a lather and washed off, patting dry.

Drug: Benzyl Peroxide

BPO and Phototherapy

EXPERIMENTAL

2 days of benzoyl peroxide washes and 3 treatments of blue light phototherapy. Pretreatment with 10% Benzoyl peroxide body wash for two consecutive days of washes prior to surgery at home. The anterior shoulder area is wet before treatment; the wash is massaged in for 20 seconds producing a lather and washed off, patting dry. The blue light phototherapy is administered to the shoulder for 3 minutes on three occasions; 2 days before, the day before surgery and in the preoperative area by the patient.

Device: Blue Light Phototherapy; Drug: Benzyl Peroxide

Interventions

Blue Light Phototherapy DEVICE

Phototherapy in the blue light spectrum

Also known as: Phototherapy

BPO and Phototherapy

Benzyl Peroxide DRUG

Benzyl peroxide wash to be used preoperatively during showering to the operative shoulder site.

Also known as: BPO

BPO Group; BPO and Phototherapy

Control OTHER

Standard surgical site preparation with no P. acnes pretreatment

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting to the practice that require a shoulder arthroplasty procedure
• English fluency and literacy
• Able to provide informed consent
• Older than 18 years of age
• Surgical indications including: primary arthritis, rotator cuff arthropathy, post-traumatic arthritis
• Primary total shoulder, hemiarthroplasty, primary reverse total shoulder or shoulder resurfacing

You may not qualify if:

• Subjects who have had a prior infection of the affected shoulder joint
• Recent steroid injection to the shoulder in the past 6 months
• Previous open or arthroscopic procedure of the shoulder joint
• Recent antibiotic use (within 90 days)
• Prisoners

Sponsors & Collaborators

• Albany Medical College: lead
• Hospital for Special Surgery, New York: collaborator

Study Sites (2)

Albany Medical Center

Albany, New York, 12208, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (12)

• Frangiamore SJ, Saleh A, Grosso MJ, Alolabi B, Bauer TW, Iannotti JP, Ricchetti ET. Early Versus Late Culture Growth of Propionibacterium acnes in Revision Shoulder Arthroplasty. J Bone Joint Surg Am. 2015 Jul 15;97(14):1149-58. doi: 10.2106/JBJS.N.00881.

  PMID: 26178890 RESULT

• Pottinger P, Butler-Wu S, Neradilek MB, Merritt A, Bertelsen A, Jette JL, Warme WJ, Matsen FA 3rd. Prognostic factors for bacterial cultures positive for Propionibacterium acnes and other organisms in a large series of revision shoulder arthroplasties performed for stiffness, pain, or loosening. J Bone Joint Surg Am. 2012 Nov 21;94(22):2075-83. doi: 10.2106/JBJS.K.00861.

  PMID: 23172325 RESULT

• Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.

  PMID: 19651954 RESULT

• Rao AJ, Chalmers PN, Cvetanovich GL, O'Brien MC, Newgren JM, Cole BJ, Verma NN, Nicholson GP, Romeo AA. Preoperative Doxycycline Does Not Reduce Propionibacterium acnes in Shoulder Arthroplasty. J Bone Joint Surg Am. 2018 Jun 6;100(11):958-964. doi: 10.2106/JBJS.17.00584.

  PMID: 29870447 RESULT

• Lee MJ, Pottinger PS, Butler-Wu S, Bumgarner RE, Russ SM, Matsen FA 3rd. Propionibacterium persists in the skin despite standard surgical preparation. J Bone Joint Surg Am. 2014 Sep 3;96(17):1447-50. doi: 10.2106/JBJS.M.01474.

  PMID: 25187583 RESULT

• Falconer TM, Baba M, Kruse LM, Dorrestijn O, Donaldson MJ, Smith MM, Figtree MC, Hudson BJ, Cass B, Young AA. Contamination of the Surgical Field with Propionibacterium acnes in Primary Shoulder Arthroplasty. J Bone Joint Surg Am. 2016 Oct 19;98(20):1722-1728. doi: 10.2106/JBJS.15.01133.

  PMID: 27869623 RESULT

• Canavan TN, Chen E, Elewski BE. Optimizing Non-Antibiotic Treatments for Patients with Acne: A Review. Dermatol Ther (Heidelb). 2016 Dec;6(4):555-578. doi: 10.1007/s13555-016-0138-1. Epub 2016 Aug 19.

  PMID: 27541148 RESULT

• Kolakowski L, Lai JK, Duvall GT, Jauregui JJ, Dubina AG, Jones DL, Williams KM, Hasan SA, Henn RF 3rd, Gilotra MN. Neer Award 2018: Benzoyl peroxide effectively decreases preoperative Cutibacterium acnes shoulder burden: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2018 Sep;27(9):1539-1544. doi: 10.1016/j.jse.2018.06.012. Epub 2018 Jul 24.

  PMID: 30054245 RESULT

• Dai T, Gupta A, Murray CK, Vrahas MS, Tegos GP, Hamblin MR. Blue light for infectious diseases: Propionibacterium acnes, Helicobacter pylori, and beyond? Drug Resist Updat. 2012 Aug;15(4):223-36. doi: 10.1016/j.drup.2012.07.001. Epub 2012 Jul 28.

  PMID: 22846406 RESULT

• Kawada A, Aragane Y, Kameyama H, Sangen Y, Tezuka T. Acne phototherapy with a high-intensity, enhanced, narrow-band, blue light source: an open study and in vitro investigation. J Dermatol Sci. 2002 Nov;30(2):129-35. doi: 10.1016/s0923-1811(02)00068-3.

  PMID: 12413768 RESULT

• Ash C, Dubec M, Donne K, Bashford T. Effect of wavelength and beam width on penetration in light-tissue interaction using computational methods. Lasers Med Sci. 2017 Nov;32(8):1909-1918. doi: 10.1007/s10103-017-2317-4. Epub 2017 Sep 12.

  PMID: 28900751 RESULT

• Oplander C, Hidding S, Werners FB, Born M, Pallua N, Suschek CV. Effects of blue light irradiation on human dermal fibroblasts. J Photochem Photobiol B. 2011 May 3;103(2):118-25. doi: 10.1016/j.jphotobiol.2011.02.018. Epub 2011 Feb 26.

  PMID: 21421326 RESULT

MeSH Terms

Interventions

Phototherapy; Benzoyl Peroxide

Intervention Hierarchy (Ancestors)

Therapeutics; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ian D Hutchinson, MD

  Albany Medical College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Orthopaedic Surgeon, Department of Surgery, Division of Orthopaedic Surgery,

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: October 2, 2019
• Study Start: January 10, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)