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

Shoulder Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03664284
• Other study ID #: 2017-01269
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2020
• Source: Hôpital du Valais
• Contact: Nicolas Gallusser, MD
• Phone: +41797453468
• Email: gallussern[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Surgery

Intervention

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).

Locations

Country	Name	City	State
Switzerland	Hopital du Valais	Martigny	Valais

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital du Valais

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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