Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes?
NCT ID: NCT04250649
Last Updated: 2020-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
105 participants
INTERVENTIONAL
2020-03-31
2024-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention
Betadine solution disinfection of the subcutaneous tissue during primary shoulder surgery
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.
Controle
Control group with surgery without disinfection of the subcutaneous tissue but dissection with an electric cautery during primary shoulder surgery
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. treated at the Valais Hospital for primary shoulder surgery.
3. have signed the consent
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Hôpital du Valais
OTHER
Responsible Party
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Principal Investigators
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Beat K Moor, PD Dr
Role: PRINCIPAL_INVESTIGATOR
Hopital du Valais
Locations
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Hôpital du Valais
Martigny-Ville, Valais, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Nicolas Gallusser, MD
Role: primary
Other Identifiers
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2020-00170
Identifier Type: -
Identifier Source: org_study_id