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

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.

Study Overview

• Status: Unknown
• Conditions: Shoulder Surgery
• Intervention / Treatment: Procedure: subcutaneous disinfection

Detailed Description

It is a randomized, single-center, open-label, category A clinical trial, a research project on people involved in the collection of biological material and the collection of health-related personal data with the existence of consent.

The investigators will study the effectiveness of Betadine subcutaneous tissue disinfection during primary shoulder surgery. They 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). The investigators estimate that 4 years is enough to recruit the number of patients needed for this study.

All patients 18 years of age or older admitted to the Valais Hospital to receive primary shoulder surgery and who have signed the consent of the study will be eligible.

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Gallusser, MD; Phone Number: +41797453468; Email: gallussern@gmail.com

Study Locations

• Switzerland
  • Valais
    • Martigny, Valais, Switzerland, 1920
      • Recruiting
      • Hopital du Valais
      • Contact: Beat K Moor, Pd Dr; Phone Number: +41 +41276039000; Email: gallussern@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. = or> 18 years
2. Supported at the Valais Hospital for primary surgery of the shoulder.
3. Have signed the consent

Exclusion Criteria:

1. <18 years old
2. History of shoulder surgery
3. History of infection of the shoulder
4. Antibiotherapy in the 2 weeks preceding the intervention
5. Infiltration of cortisone in the 6 months preceding the intervention
6. Iodinated contrast medium allergy or cefuroxime

7. 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)

8. Refusal of the terms of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Active Comparator: intervention group	Procedure: subcutaneous disinfection; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hôpital du Valais
• Investigators: Principal Investigator: Beat K Moor, PD Dr, Hopital du Valais

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017-01269

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No