Surgical Incision
Conditions
Keywords
subcutaneous desinfection, P. acnes, electric cautery
Brief 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.
Interventions
PROCEDUREsubcutaneous 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.
Sponsors
Hôpital du Valais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
A standard block randomization strategy will be used. The ratio between intervention and control will be set at 2: 1. This will facilitate recruitment and provide more information on the effectiveness of the intervention. The randomization sequence will be created using the STATA program.
Intervention model description
This is a single center, category A randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| positive sample | 4 years | 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. |
Countries
Switzerland
Contacts
Primary ContactNicolas Gallusser
Outcome results
None listed