Does the Disinfection of the Subcutaneous Tissue Reduce the Contamination of the Operative Field by P. Acnes During Primary Shoulder Surgery?

NCT03664284 | Unknown

• 1 other identifier: 2017-01269
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Propionibacterium acnes is a pathogen frequently identified during postoperative infections of the shoulder. A recent study has shown that P. acnes is likely to be disseminated in the operative field from the subcutaneous layer by soft tissue manipulation by the surgeon and the instruments (Falconer 2016). This study seeks to evaluate the effectiveness of subcutaneous tissue disinfection on P. acnes contamination during primary shoulder surgery. The literature shows that approximately one-third of patients have a P. acnes-infected surgical drape during primary shoulder arthroplasty (Falconer 2016). The source of this contamination would be the subcutaneous tissue. The hypothesis is that a disinfection of the subcutaneous tissue would reduce the contamination of the operative field with the aim of reducing the infection rate after shoulder surgery.

Conditions

Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• positive bacteriological sample

  To compare the positive bacteriological sample rate during open shoulder surgery with subcutaneous tissue disinfection compared to an identical procedure that does not include this step.

  operation day

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Procedure: subcutaneous disinfection

control group

NO INTERVENTION

Interventions

subcutaneous disinfection PROCEDURE

The investigators will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B).

intervention group

Eligibility Criteria

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

You may qualify if:

• = or\> 18 years
• Supported at the Valais Hospital for primary surgery of the shoulder.
• Have signed the consent

You may not qualify if:

• \<18 years old
• History of shoulder surgery
• History of infection of the shoulder
• Antibiotherapy in the 2 weeks preceding the intervention
• Infiltration of cortisone in the 6 months preceding the intervention
• Iodinated contrast medium allergy or cefuroxime
• Allergy to the povidone iodine complex or other contraindication to Betadine namely:
• Hypersensitivity to the active ingredient, iodine or povidone iodine complex, or to any of the excipients according to the composition.
• Hyperthyroidism and other overt thyroid diseases. Dermatitis herpetiformis of Duhring. Before and after radioactive iodine treatment (until the end of treatment)
• Refusal of the terms of the study

Sponsors & Collaborators

• Hôpital du Valais: lead

Study Sites (1)

Hopital du Valais

Martigny-Ville, Valais, 1920, Switzerland

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Study Officials

• Beat K Moor, PD Dr

  Hopital du Valais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Gallusser, MD

CONTACT

+41797453468; gallussern@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr Moor, Head of departement of orthopedic surgery, Principal investigator

Model Details: The investigators will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B).

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 10, 2018
• Study Start: February 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

CH (1)