C. AcnesNCT04483063
Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?
A study testing 2% chlorhexidine gluconate skin cleanser in people with C. Acnes and Arthroscopic Rotator Cuff Repair, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The purpose of our study was to investigate whether preoperative skin cleaning on face, neck, and chest with chlorhexidine could reduce suture contamination of C. acnes in arthroscopic rotator cuff repair. We hypothesized that preoperative skin cleaning on face, neck and chest with chlorhexidine can reduce C. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- C. Acnes, Arthroscopic Rotator Cuff Repair
- What is being tested?
- 2% chlorhexidine gluconate skin cleanser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Mar 2020to 30 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary arthroscopic rotator cuff repair
Who cannot join
- younger than 18 years
- having previous shoulder surgeries or shoulder infection episodes
- having a history of allergy to chlorhexidine
- who refused to participate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 70428
National Cheng Kung U Hospital
About this study
The purpose of our study was to investigate whether preoperative skin cleaning on face, neck, and chest with chlorhexidine could reduce suture contamination of C. acnes in arthroscopic rotator cuff repair. We hypothesized that preoperative skin cleaning on face, neck and chest with chlorhexidine can reduce C. acnes contamination on sutures in arthroscopic rotator cuff repair.
- Conditions
- C. Acnes, Arthroscopic Rotator Cuff Repair
- Being tested
- 2% chlorhexidine gluconate skin cleanser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidine gluconate skin cleanserDrug
2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery
| Study group | Role | What they receive |
|---|---|---|
| Extended shoulder group | Experimental | 2% chlorhexidine gluconate skin cleanser over the not only the operative shoulder and axilla but also the chest, back, neck, and face Receives: Drug: 2% chlorhexidine gluconate skin cleanser |
| Shoulder group | Experimental | 2% chlorhexidine gluconate skin cleanser over the operative shoulder and axilla Receives: Drug: 2% chlorhexidine gluconate skin cleanser |
| Control group | No intervention | Skin prepare with soap as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture positive
Culture positive for C. acnes from the suture used in the arthroscopy
Measured: Within 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start23 Mar 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C. AcnesStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai-Lan Hsu, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483063
- Sponsor's protocol ID
- B-BR-108-052
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2020
- Last updated
- 23 Jul 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 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?
- ClinicalTrials.gov ID
- NCT04483063
- Acronym / sponsor ID
- B-BR-108-052
- Conditions
- C. Acnes, Arthroscopic Rotator Cuff Repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 23 Jul 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.
The purpose of our study was to investigate whether preoperative skin cleaning on face, neck, and chest with chlorhexidine could reduce suture contamination of C. acnes in arthroscopic rotator cuff repair. We hypothesized that preoperative skin cleaning on face, neck and chest with chlorhexidine can reduce C. acnes contamination on sutures in arthroscopic rotator cuff repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extended shoulder group | Experimental | Drug: 2% chlorhexidine gluconate skin cleanser2% chlorhexidine gluconate skin cleanser over the not only the operative shoulder and axilla but also the chest, back, neck, and face |
| Shoulder group | Experimental | Drug: 2% chlorhexidine gluconate skin cleanser2% chlorhexidine gluconate skin cleanser over the operative shoulder and axilla |
| Control group | No intervention | –Skin prepare with soap as usual |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary arthroscopic rotator cuff repair
Key exclusion criteria (4 listed)
- younger than 18 years
- having previous shoulder surgeries or shoulder infection episodes
- having a history of allergy to chlorhexidine
- who refused to participate
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 |
|---|---|---|
| 2% chlorhexidine gluconate skin cleanser2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery | Drug | Extended shoulder group, Shoulder group |
Primary outcome
Culture positive
Time frame: Within 2 weeks postoperatively
Culture positive for C. acnes from the suture used in the arthroscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% chlorhexidine gluconate skin cleanser in people with C. Acnes and Arthroscopic Rotator Cuff Repair, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 23 Jul 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 Taiwan. 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 Chih-Kai Hong, MD (886-6-2353535 ext. 5237, yayahong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culture positive (time frame: Within 2 weeks postoperatively). 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 23 Jul 2020.