Shoulder SurgeryNCT03664284
Does the Disinfection of the Subcutaneous Tissue Reduce the Contamination of the Operative Field by P. Acnes During Primary Shoulder Surgery?
A study testing subcutaneous disinfection in people with Shoulder Surgery, run by Hôpital du Valais at 1 site in Switzerland.
Trial summary
Propionibacterium acnes is a pathogen frequently identified during postoperative infections of the shoulder. A recent study has shown that P. acnes is likely to be disseminated in the operative field from the subcutaneous layer by soft tissue manipulation by the surgeon and the instruments (Falconer 2016). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- subcutaneous 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
- 1 Feb 2019to 1 Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- = or> 18 years
- Supported at the Valais Hospital for primary surgery of the shoulder.
- Have signed the consent
Who cannot join
- <18 years old
- History of shoulder surgery
- History of infection of the shoulder
- Antibiotherapy in the 2 weeks preceding the intervention
- Infiltration of cortisone in the 6 months preceding the intervention
- Iodinated contrast medium allergy or cefuroxime
Show all 10Show fewer
- Allergy to the povidone iodine complex or other contraindication to Betadine namely:
- Hypersensitivity to the active ingredient, iodine or povidone iodine complex, or to any of the excipients according to the composition.
- Hyperthyroidism and other overt thyroid diseases. Dermatitis herpetiformis of Duhring. Before and after radioactive iodine treatment (until the end of treatment)
- Refusal of the terms of the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Hopital du Valais
Martigny-Ville, Valais, 1920
Beat K Moor, Pd Dr, +41276039000 ext. +41, gallussern@gmail.com
About this study
Propionibacterium acnes is a pathogen frequently identified during postoperative infections of the shoulder. A recent study has shown that P. acnes is likely to be disseminated in the operative field from the subcutaneous layer by soft tissue manipulation by the surgeon and the instruments (Falconer 2016). This study seeks to evaluate the effectiveness of subcutaneous tissue disinfection on P. acnes contamination during primary shoulder surgery. The literature shows that approximately one-third of patients have a P. acnes-infected surgical drape during primary shoulder arthroplasty (Falconer 2016). The source of this contamination would be the subcutaneous tissue. The hypothesis is that a disinfection of the subcutaneous tissue would reduce the contamination of the operative field with the aim of reducing the infection rate after shoulder surgery.
Read the detailed description
It is a randomized, single-center, open-label, category A clinical trial, a research project on people involved in the collection of biological material and the collection of health-related personal data with the existence of consent.
The investigators will study the effectiveness of Betadine subcutaneous tissue disinfection during primary shoulder surgery. They will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B). The investigators estimate that 4 years is enough to recruit the number of patients needed for this study.
All patients 18 years of age or older admitted to the Valais Hospital to receive primary shoulder surgery and who have signed the consent of the study will be eligible.
- Conditions
- Shoulder Surgery
- Being tested
- subcutaneous disinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous disinfectionProcedure or surgery
The investigators will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | Not described Receives: Procedure: subcutaneous disinfection |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive bacteriological sample
To compare the positive bacteriological sample rate during open shoulder surgery with subcutaneous tissue disinfection compared to an identical procedure that does not include this step.
Measured: operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Feb 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder SurgeryStudies 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
- The investigators will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sina Grape, Hôpital du Valais
- Investigators
- Beat K Moor, PD Dr, Principal investigator, Hopital du Valais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664284
- Sponsor's protocol ID
- 2017-01269
- Other IDs
- 2017
- Status last verified
- Feb 2020
- First submitted
- 7 Sep 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Falconer TM, Baba M, Kruse LM, Dorrestijn O, Donaldson MJ, Smith MM, Figtree MC, Hudson BJ, Cass B, Young AA. Contamination of the Surgical Field with Propionibacterium acnes in Primary Shoulder Arthroplasty. J Bone Joint Surg Am. 2016 Oct 19;98(20):1722-1728. doi: 10.2106/JBJS.15.01133.
PubMed 27869623
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Disinfection of the Subcutaneous Tissue Reduce the Contamination of the Operative Field by P. Acnes During Primary Shoulder Surgery?
- ClinicalTrials.gov ID
- NCT03664284
- Acronym / sponsor ID
- 2017-01269
- Conditions
- Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 10 Sep 2018 (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 frequently identified during postoperative infections of the shoulder. A recent study has shown that P. acnes is likely to be disseminated in the operative field from the subcutaneous layer by soft tissue manipulation by the surgeon and the instruments (Falconer 2016). This study seeks to evaluate the effectiveness of subcutaneous tissue disinfection on P. acnes contamination during primary shoulder surgery. The literature shows that approximately one-third of patients have a P. acnes-infected surgical drape during primary shoulder arthroplasty (Falconer 2016). The source of this contamination would be the subcutaneous tissue. The hypothesis is that a disinfection of the subcutaneous tissue would reduce the contamination of the operative field with the aim of reducing the infection rate after shoulder surgery.
Detailed description
It is a randomized, single-center, open-label, category A clinical trial, a research project on people involved in the collection of biological material and the collection of health-related personal data with the existence of consent.
The investigators will study the effectiveness of Betadine subcutaneous tissue disinfection during primary shoulder surgery. They will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B). The investigators estimate that 4 years is enough to recruit the number of patients needed for this study.
All patients 18 years of age or older admitted to the Valais Hospital to receive primary shoulder surgery and who have signed the consent of the study will be eligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The investigators will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B).
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Procedure: subcutaneous disinfection |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- = or> 18 years
- Supported at the Valais Hospital for primary surgery of the shoulder.
- Have signed the consent
Key exclusion criteria (10 listed)
- <18 years old
- History of shoulder surgery
- History of infection of the shoulder
- Antibiotherapy in the 2 weeks preceding the intervention
- Infiltration of cortisone 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 disinfectionThe investigators will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B). | Procedure or surgery | intervention group |
Primary outcome
positive bacteriological sample
Time frame: operation day
To compare the positive bacteriological sample rate during open shoulder surgery with subcutaneous tissue disinfection compared to an identical procedure that does not include this step.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 27869623Falconer TM, Baba M, Kruse LM, Dorrestijn O, Donaldson MJ, Smith MM, Figtree MC, Hudson BJ, Cass B, Young AA. Contamination of the Surgical Field with Propionibacterium acnes in Primary Shoulder Arthroplasty. J Bone Joint Surg Am. 2016 Oct 19;98(20):1722-1728. doi: 10.2106/JBJS.15.01133.
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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 disinfection in people with Shoulder Surgery, 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 10 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 13 Feb 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, MD (+41797453468, gallussern@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive bacteriological sample (time frame: operation day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03664284, which also lists 1 linked publication.
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 13 Feb 2020.