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

NCT ID: NCT03664284

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-10-01

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.

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.

Conditions

Shoulder Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention group

Group Type: ACTIVE_COMPARATOR

subcutaneous disinfection

Intervention Type: 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).

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hôpital du Valais

OTHER

Sponsor Role: lead

Responsible Party

Sina Grape

PD Dr Moor, Head of departement of orthopedic surgery, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beat K Moor, PD Dr

Role: PRINCIPAL_INVESTIGATOR

Hopital du Valais

Locations

Hopital du Valais

Martigny-Ville, Valais, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Nicolas Gallusser, MD

Role: CONTACT

gallussern@gmail.com

+41797453468

Facility Contacts

Beat K Moor, Pd Dr

Role: primary

gallussern@gmail.com

+41276039000 ext. +41

References

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.

Reference Type: BACKGROUND

PMID: 27869623 (View on PubMed)

Other Identifiers

2017-01269

Identifier Type: -

Identifier Source: org_study_id