Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes? (Elec_cautery)

Hôpital du Valais

Status: Unknown

Conditions: Surgical Incision

Treatments: Procedure: subcutaneous tissue disinfection

Study type: Interventional

Funder types: Other

Identifiers

NCT04250649

2020-00170

Details and patient eligibility

About

Propionibacterium acnes is a pathogen commonly identified in postoperative shoulder infections. A recent study has shown that P. acnes is likely to be disseminated in the operating field from the subcutaneous layer by the manipulation of soft tissues by the surgeon and the instruments. Disinfection of the subcutaneous tissue seems to significantly reduce contamination of the operating field during primary shoulder surgery. This study seeks to assess the efficacy of disinfection of the subcutaneous tissue compared to dissection with an electrosurgical unit on P. acnes contamination during primary shoulder surgery.

Full description

The investigators are going to study the efficacy of disinfecting the subcutaneous tissue with Betadine standard solution during primary shoulder surgery compared to electrosurgical dissection. They will randomize 105 patients on two arms. The control group receiving no disinfection of the subcutaneous tissue but a dissection with an electric cautery(A) and intervention group receiving a disinfection of the subcutaneous tissue (B). They believe that the duration of 4 years is sufficient to recruit the number of patients necessary for this study.

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

The use of disinfection of the subcutaneous tissue during primary shoulder surgery could reduce contamination of the operating field and theoretically the post-operative infection rate after primary shoulder surgery.

The study focuses on disinfection with Betadine solution of the subcutaneous tissue during primary shoulder surgery. This action could decrease contamination of the operating field and the infection rate after primary shoulder surgery.

This solution is already widely used for disinfecting the skin and traumatic or surgical wounds.

The investigators will use it according to the recommendations made in the Swiss Compendium of Medicines.

No evidence has been brought to a decrease in this contamination if the dissection is carried out with an electric cautery. Scalpel dissection is used as standard in orthopedic surgery as well as in other surgical disciplines.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. = or> 18 years old
2. treated at the Valais Hospital for primary shoulder surgery.
3. have signed the consent

Exclusion criteria

1. <18 years old
2. History of shoulder surgery
3. History of shoulder infection
4. Antibiotic therapy in the 2 weeks preceding the intervention
5. Cortisone infiltration in the 6 months preceding the intervention
6. Allergy to iodinated contrast agent or Cefuroxime
7. Allergy to povidone iodine complex or other contraadication to Betadine
8. Refusal of study terms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups

Intervention

Active Comparator group

Description:

Betadine solution disinfection of the subcutaneous tissue during primary shoulder surgery

Treatment:

Procedure: subcutaneous tissue disinfection

Controle

No Intervention group

Description:

Control group with surgery without disinfection of the subcutaneous tissue but dissection with an electric cautery during primary shoulder surgery