P.Acnes Colony Count Following Subdermal Cefazolin

NCT03853096 | Unknown Early Phase 1 DMC

• 1 other identifier: H16-01432
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The specific outcome is to determine whether the colony count of Propionibacterium acnes, one of the commonest causes of shoulder infection and not eradicated by conventional forms of surgical preparatory solutions and antibiotics, in a shoulder surgical wound will be altered by the use of subdermal cefazolin.

Conditions

Surgical Site Infection; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• Change in P.acnes colony count

  Colony count before and 60 minutes after subcutaneous cefazolin administration

  Baseline tissue sampling prior to subcutaneous antibiotic administration, and tissue sampling 60 minutes after

Study Arms (1)

Subcutaneous cefazolin arm

EXPERIMENTAL

A patient receiving a standard deltopectoral approach will have the planned incision site divided into thirds. This will produce 6 segments. Each segment will be biopsied using a commercially available dermatology punch and sent for colony count prior to local antibiotic infiltration. Cefazolin will be administered to one half of the incision only, into three segments. Following 60 minutes of operative time, the biopsies will be repeated and sent for colony count for comparison. Cefazolin administered will be 100mg/mL in 3 aliquots for 3 site administrations leading to a total subcutaneous injection of approximately 900mg. There will be a one time administration of the antibiotics in a subcutaneous route.

Drug: Cefazolin

Interventions

Cefazolin DRUG

Cefazolin 100mg/mL, 3mL in three locations will be administered around a surgical incision on the anterior shoulder in a standard deltopectoral approach interval. This will be a one time administration. Administration and route will be subcutaneous.

Subcutaneous cefazolin arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than or equal to 18
• patients requiring deltopectoral approach and opening of joint capsule for primary shoulder surgery

You may not qualify if:

• allergy to cefazolin or cephalosporins
• tattoos over operative site
• previous surgical site infections in either shoulder
• revision surgical procedure
• immunocompromised patients

Sponsors & Collaborators

• University of British Columbia: lead

Related Publications (10)

• Harb G, Lebel F, Battikha J, Thackara JW. Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin. 2010 Feb;26(2):279-88. doi: 10.1185/03007990903432900.

  PMID: 19947907 BACKGROUND

• Quendt J, Blank I, Seidel W. [Peritoneal and subcutaneous administration of cefazolin as perioperative antibiotic prophylaxis in colorectal operations. Prospective randomized comparative study of 200 patients]. Langenbecks Arch Chir. 1996;381(6):318-22. doi: 10.1007/BF00191311. German.

  PMID: 9082104 BACKGROUND

• Achermann Y, Goldstein EJ, Coenye T, Shirtliff ME. Propionibacterium acnes: from commensal to opportunistic biofilm-associated implant pathogen. Clin Microbiol Rev. 2014 Jul;27(3):419-40. doi: 10.1128/CMR.00092-13.

  PMID: 24982315 BACKGROUND

• Klein JA, Langman LJ. Prevention of Surgical Site Infections and Biofilms: Pharmacokinetics of Subcutaneous Cefazolin and Metronidazole in a Tumescent Lidocaine Solution. Plast Reconstr Surg Glob Open. 2017 May 30;5(5):e1351. doi: 10.1097/GOX.0000000000001351. eCollection 2017 May.

  PMID: 28607871 BACKGROUND

• Saper D, Capiro N, Ma R, Li X. Management of Propionibacterium acnes infection after shoulder surgery. Curr Rev Musculoskelet Med. 2015 Mar;8(1):67-74. doi: 10.1007/s12178-014-9256-5.

  PMID: 25596729 BACKGROUND

• Noriega OD, Yarleque Leon SN. Antibiotics by Subcutaneous Route: A Safe and Efficient Alternative. J Am Med Dir Assoc. 2018 Jun;19(6):553-554. doi: 10.1016/j.jamda.2018.03.011. Epub 2018 Apr 27. No abstract available.

  PMID: 29709392 BACKGROUND

• Dubrovsky G, Huynh N, Rouch JD, Koulakis JP, Nicolau DP, Sutherland CA, Putterman S, Dunn JCY. Subcutaneous cefazolin to reduce surgical site infections in a porcine model. J Surg Res. 2018 Apr;224:156-159. doi: 10.1016/j.jss.2017.11.056. Epub 2017 Dec 28.

  PMID: 29506833 BACKGROUND

• Forestier E, Paccalin M, Roubaud-Baudron C, Fraisse T, Gavazzi G, Gaillat J. Subcutaneously administered antibiotics: a national survey of current practice from the French Infectious Diseases (SPILF) and Geriatric Medicine (SFGG) society networks. Clin Microbiol Infect. 2015 Apr;21(4):370.e1-3. doi: 10.1016/j.cmi.2014.11.017. Epub 2014 Nov 23.

  PMID: 25658521 BACKGROUND

• Cockshott WP, Thompson GT, Howlett LJ, Seeley ET. Intramuscular or intralipomatous injections? N Engl J Med. 1982 Aug 5;307(6):356-8. doi: 10.1056/NEJM198208053070607. No abstract available.

  PMID: 7088101 BACKGROUND

• Levy PY, Fenollar F, Stein A, Borrione F, Cohen E, Lebail B, Raoult D. Propionibacterium acnes postoperative shoulder arthritis: an emerging clinical entity. Clin Infect Dis. 2008 Jun 15;46(12):1884-6. doi: 10.1086/588477.

  PMID: 18462110 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Communicable Diseases

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• William Regan

  UBC clinical professor in orthopaedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Regan

CONTACT

1-866-737-7460; bill.regan@ubc.ca

Ryan Lohre

CONTACT

1-604-317-3275

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 20 patient pilot study, single arm prospectively collected with no blinding or randomization. Consenting patients will receive at time of surgery an additional subcutaneous cefazolin injection at the surgical site as well as timed tissue biopsies for colony count of P.acnes

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 25, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share