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

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ClinicalTrials.gov Identifier: NCT03664284
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sina Grape, Hôpital du Valais

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.

Condition or disease Intervention/treatment Phase
Shoulder Surgery Procedure: subcutaneous disinfection Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Does the Disinfection of the Subcutaneous Tissue Reduce the Contamination of the Operative Field by P. Acnes During Primary Shoulder Surgery?
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).

No Intervention: control group



Primary Outcome Measures :
  1. positive bacteriological sample [ Time Frame: operation day ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664284


Contacts
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Contact: Nicolas Gallusser, MD +41797453468 gallussern@gmail.com

Sponsors and Collaborators
Hôpital du Valais

Publications:
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Responsible Party: Sina Grape, PD Dr Moor, Head of departement of orthopedic surgery, Principal investigator, Hôpital du Valais
ClinicalTrials.gov Identifier: NCT03664284     History of Changes
Other Study ID Numbers: 2017-01269
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No