NCT04250649

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Hôpital du Valais · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Surgical Incision

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-03-31
• Primary completion: 2022-03-31
• Completion: 2024-03-31
• First posted: 2020-01-31
• Last updated: 2020-01-31

Locations

1 site across 1 country: Switzerland