Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes? (Elec_cautery)
Primary Purpose
Surgical Incision
Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
subcutaneous tissue disinfection
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Incision focused on measuring subcutaneous desinfection, P. acnes, electric cautery
Eligibility Criteria
Inclusion Criteria:
- = or> 18 years old
- treated at the Valais Hospital for primary shoulder surgery.
- have signed the consent
Exclusion Criteria:
- <18 years old
- History of shoulder surgery
- History of shoulder infection
- Antibiotic therapy in the 2 weeks preceding the intervention
- Cortisone infiltration in the 6 months preceding the intervention
- Allergy to iodinated contrast agent or Cefuroxime
- Allergy to povidone iodine complex or other contraadication to Betadine
- Refusal of study terms
Sites / Locations
- Hôpital du Valais
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Controle
Arm Description
Betadine solution disinfection of the subcutaneous tissue during primary shoulder surgery
Control group with surgery without disinfection of the subcutaneous tissue but dissection with an electric cautery during primary shoulder surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04250649
Brief Title
Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes?
Acronym
Elec_cautery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 31, 2020 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital du Valais
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision
Keywords
subcutaneous desinfection, P. acnes, electric cautery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single center, category A randomized clinical trial.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Betadine solution disinfection of the subcutaneous tissue during primary shoulder surgery
Arm Title
Controle
Arm Type
No Intervention
Arm Description
Control group with surgery without disinfection of the subcutaneous tissue but dissection with an electric cautery during primary shoulder surgery
Intervention Type
Procedure
Intervention Name(s)
subcutaneous tissue disinfection
Intervention Description
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.
Primary Outcome Measure Information:
Title
positive sample
Description
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.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
= or> 18 years old
treated at the Valais Hospital for primary shoulder surgery.
have signed the consent
Exclusion Criteria:
<18 years old
History of shoulder surgery
History of shoulder infection
Antibiotic therapy in the 2 weeks preceding the intervention
Cortisone infiltration in the 6 months preceding the intervention
Allergy to iodinated contrast agent or Cefuroxime
Allergy to povidone iodine complex or other contraadication to Betadine
Refusal of study terms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Gallusser
Phone
027 603 90 00
Ext
+41
Email
gallussern@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beat K Moor, PD Dr
Organizational Affiliation
Hopital du Valais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital du Valais
City
Martigny
State/Province
Valais
ZIP/Postal Code
1920
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Gallusser, MD
Phone
027 603 90 00
Ext
+41
Email
gallussern@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes?
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