Surgical IncisionElec_cauteryNCT04250649
Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes?
A study testing subcutaneous tissue disinfection in people with Surgical Incision, run by Hôpital du Valais at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Incision
- What is being tested?
- subcutaneous tissue disinfection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Mar 2020to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- = or> 18 years old
- treated at the Valais Hospital for primary shoulder surgery.
- have signed the consent
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpital du Valais
Martigny-Ville, Valais, 1920
Nicolas Gallusser, MD, 027 603 90 00 ext. +41, gallussern@gmail.com
About this study
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
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.
Read the 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
- Being tested
- subcutaneous tissue disinfection
- Keywords
- subcutaneous desinfection, P. acnes, electric cautery
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous tissue disinfectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Betadine solution disinfection of the subcutaneous tissue during primary shoulder surgery Receives: Procedure: subcutaneous tissue disinfection |
| Controle | No intervention | Control group with surgery without disinfection of the subcutaneous tissue but dissection with an electric cautery during primary shoulder surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start31 Mar 2020 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, category A randomized clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beat K Moor, PD Dr, Principal investigator, Hopital du Valais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250649
- Sponsor's protocol ID
- 2020-00170
- Acronym
- Elec_cautery
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04250649
- Acronym / sponsor ID
- Elec_cautery / 2020-00170
- Conditions
- Surgical Incision
- Keywords
- subcutaneous desinfection, P. acnes, electric cautery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Study start
- 31 Mar 2020 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single center, category A randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Procedure: subcutaneous tissue disinfectionBetadine solution disinfection of the subcutaneous tissue during primary shoulder surgery |
| Controle | No intervention | –Control group with surgery without disinfection of the subcutaneous tissue but dissection with an electric cautery during primary shoulder surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- = or> 18 years old
- treated at the Valais Hospital for primary shoulder surgery.
- have signed the consent
Key exclusion criteria (8 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcutaneous tissue disinfectionSkin 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. | Procedure or surgery | Intervention |
Primary outcome
positive sample
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beat K Moor, PD Dr principal investigator
Hopital du Valais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous tissue disinfection in people with Surgical Incision, run by Hôpital du Valais at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Gallusser (027 603 90 00 ext. +41, gallussern@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive sample (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.