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

Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes Compared to Dissection With an Electric Cautery During Primary Shoulder Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Incision
• Intervention / Treatment: Procedure: subcutaneous tissue disinfection

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Gallusser; Phone Number: +41 027 603 90 00; Email: gallussern@gmail.com

Study Locations

• Switzerland
  • Valais
    • Martigny, Valais, Switzerland, 1920
      • Hopital du Valais
      • Contact: Nicolas Gallusser, MD; Phone Number: +41 027 603 90 00; Email: gallussern@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Betadine solution disinfection of the subcutaneous tissue during primary shoulder surgery	Procedure: subcutaneous tissue disinfection; Skin and subcutaneous incision (up to the muscular fascia) with "superficial blade" scalpel, disinfection of the subcutaneous tissue with 3cc of Betadine solution, placement of the retractors, dissection and development of the delto-pectoral interval with "deep blade" scalpel. When the joint is opened, bacteriological smears are taken from 5 sites in the two groups. 1) exposed subcutaneous tissue, 2) surgeon's gloves (distal end of fingers), 3) "superficial blade", 4) "deep blade", 5) retractors. The rest of the shoulder surgery procedure does not differ from what is commonly performed. The samples are sent to bacteriology for bacterial culture. Anaerobic research is done specifically for P. acnes. The results are considered negative after 10 days.
No Intervention: Controle; Control group with surgery without disinfection of the subcutaneous tissue but dissection with an electric cautery during primary shoulder surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive sample	Compare the positive bacteriological sample rate during an open shoulder surgery procedure with a disinfection of the subcutaneous tissue compared to an operating procedure without disinfection but dissection with an electric knife.	4 years

Collaborators and Investigators

• Sponsor: Hôpital du Valais
• Investigators: Principal Investigator: Beat K Moor, PD Dr, Hopital du Valais

Study record dates

Study Major Dates

• Study Start (Anticipated): March 31, 2020
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: subcutaneous desinfection, P. acnes, electric cautery
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 2020-00170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No