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

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    105
  • sponsor
    Hôpital du Valais
Updated on 27 February 2022
Accepts healthy volunteers

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.

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.

Details
Condition Shoulder Surgery
Treatment subcutaneous disinfection
Clinical Study IdentifierNCT03664284
SponsorHôpital du Valais
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

<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
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