Hallux ValgusPhase 3NCT01583192
Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery
A Phase 3 study testing skin preparation in people with Hallux Valgus and Arthritis of the First Metatarsophalangeal Joint, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
The study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Arthritis of the First Metatarsophalangeal Joint
- What is being tested?
- skin preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2013to Jun 2014
- Phase
- Phase 3
- 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
- age above 18 years
- written informed consent
- indication for hallux valgus correction or arthrodesis of the first metatarsophalageal joint
Who cannot join
- allergic for jodine-povidine and/or chloride-hexidine
- active infection
- skin defect
- blood clotting or coagulation disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Chloridehexidine/Alcohol Versus Jodine/Povidine in Forefoot Surgery
The study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery.
Read the detailed description
It will be a comparative study in which we will swab cultures before skin preparation directly after skin preparation and at the and of the operation (hallux valgus correction and arthrodesis of the first metatarsophalangeal joint.
There will be a quantitative and quality analysis of the swabs. We will also measure allergic reactions. During the post-operative period of 6 weeks we will measure the wound infections stated by Prezies.
- Being tested
- skin preparation
- Keywords
- infection, skin preparation, fore-foot surgery, chloride-hexidine, povidine-jodine, alcohol
- Medical subject headings
- Hallux Valgus, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin preparationProcedure or surgery
skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%
| Study group | Role | What they receive |
|---|---|---|
| chloride-hexidine soluted in alcohol | Active comparator | patients will have skin preparation with chloride-hexidine soluted in alcohol prior to their forefoot surgery.
Skin swabs will be taken prior to skin preparation, after skin preparation and after skin closure at the end of the operation Receives: Procedure: skin preparation |
| povidine-jodine soluted in alcohol | Active comparator | skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery. Receives: Procedure: skin preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of positive swab cultures
During surgery swabs will be taken before skin desinfection, after skin desinfection and at the end of the surgery.
We will count the number of positive swab cultures taken from the webspace of their first and second toe and at the place of incision 48 hours post-operatively.
Measured: From start surgery week until 48 hours post-operatively
wound infection
we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively
Measured: until 6 weeks postoperatively
Secondary outcomes (1)
Allergic events
we will look at the number of allergic events occuring.
Measured: Until 6 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 Apr 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Speth, St. Antonius Hospital
- Investigators
- Mario Speth, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583192
- Sponsor's protocol ID
- mbshadid
- Status last verified
- Jun 2014
- First submitted
- 23 Mar 2012
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Chloridehexidine/Alcohol Versus Jodine/Povidine in Forefoot Surgery
- ClinicalTrials.gov ID
- NCT01583192
- Acronym / sponsor ID
- mbshadid
- Keywords
- infection, skin preparation, fore-foot surgery, chloride-hexidine, povidine-jodine, alcohol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Apr 2012 (estimated)
- 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 study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery.
Detailed description
It will be a comparative study in which we will swab cultures before skin preparation directly after skin preparation and at the and of the operation (hallux valgus correction and arthrodesis of the first metatarsophalangeal joint.
There will be a quantitative and quality analysis of the swabs. We will also measure allergic reactions. During the post-operative period of 6 weeks we will measure the wound infections stated by Prezies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chloride-hexidine soluted in alcohol | Active comparator | Procedure: skin preparationpatients will have skin preparation with chloride-hexidine soluted in alcohol prior to their forefoot surgery. Skin swabs will be taken prior to skin preparation, after skin preparation and after skin closure at the end of the operation |
| povidine-jodine soluted in alcohol | Active comparator | Procedure: skin preparationskin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot 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)
- age above 18 years
- written informed consent
- indication for hallux valgus correction or arthrodesis of the first metatarsophalageal joint
Key exclusion criteria (4 listed)
- allergic for jodine-povidine and/or chloride-hexidine
- active infection
- skin defect
- blood clotting or coagulation disorder
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 |
|---|---|---|
| skin preparationskin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70% | Procedure or surgery | chloride-hexidine soluted in alcohol, povidine-jodine soluted in alcohol |
Primary outcome
number of positive swab cultures
Time frame: From start surgery week until 48 hours post-operatively
During surgery swabs will be taken before skin desinfection, after skin desinfection and at the end of the surgery. We will count the number of positive swab cultures taken from the webspace of their first and second toe and at the place of incision 48 hours post-operatively.
wound infection
Time frame: until 6 weeks postoperatively
we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively
1 secondary outcome
Allergic events
Time frame: Until 6 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- woundinfection criteriaLink provided by the sponsor.
Related trials for Hallux Valgus
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingObservational study
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
Hallux Valgus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Not yet recruitingObservational study
Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery
Postoperative Chronic Pain, Hallux Valgus Surgery
Recruiting
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Hallux Valgus, Orthopedic Disorder
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.
Mario Speth, MD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing skin preparation in people with Hallux Valgus and Arthritis of the First Metatarsophalangeal Joint, run by St. Antonius Hospital at 1 site in Netherlands.
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 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: finished, as of the sponsor's last update on 9 Jun 2014. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of positive swab cultures (time frame: From start surgery week until 48 hours post-operatively). The study lists 2 primary outcomes in all. 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 9 Jun 2014.