Surgical Wound InfectionNCT02919410
Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial
A study testing iodophor-impregnated adhesive drapes and No adhesive drapes in people with Surgical Wound Infection, run by Rothman Institute Orthopaedics.
Trial summary
This is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- iodophor-impregnated adhesive drapes and No adhesive drapes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2014to May 2016
- 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
- Adult, Older adult
Who may be able to join
- Primary femoroacetabular osteoplasty (FAO) patients
- Primary Periacetabular Osteotomy (PAO) patients
Who cannot join
- Total hip arthroplasty (THA) patients
- Revision FAO surgery
- Septic or septic arthritis patients
- Patients with systemic or topical allergy to iodine
About this study
This is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.
- Conditions
- Surgical Wound Infection
- Being tested
- iodophor-impregnated adhesive drapes, No adhesive drapes
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodophor-impregnated adhesive drapesDevice
No adhesive drapesOther
| Study group | Role | What they receive |
|---|---|---|
| Surgery performed using iodophor-impregnated adhesive drapes | Active comparator | Not described Receives: Device: iodophor-impregnated adhesive drapes |
| Surgery performed without iodophor-impregnated adhesive drapes | Other | Not described Receives: Other: No adhesive drapes |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial count from skin swabs
Measured: Immediately post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies 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
- Prevention
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919410
- Sponsor's protocol ID
- JPAR2015
- Status last verified
- Sep 2016
- First submitted
- 27 Sep 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT02919410
- Acronym / sponsor ID
- JPAR2015
- Conditions
- Surgical Wound Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- First posted
- 29 Sep 2016 (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.
This is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.
Study design
- Primary purpose
- Prevention
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery performed using iodophor-impregnated adhesive drapes | Active comparator | Device: iodophor-impregnated adhesive drapes |
| Surgery performed without iodophor-impregnated adhesive drapes | Other | Other: No adhesive drapes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary femoroacetabular osteoplasty (FAO) patients
- Primary Periacetabular Osteotomy (PAO) patients
Key exclusion criteria (4 listed)
- Total hip arthroplasty (THA) patients
- Revision FAO surgery
- Septic or septic arthritis patients
- Patients with systemic or topical allergy to iodine
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 |
|---|---|---|
| iodophor-impregnated adhesive drapes | Device | Surgery performed using iodophor-impregnated adhesive drapes |
| No adhesive drapes | Other | Surgery performed without iodophor-impregnated adhesive drapes |
Primary outcome
bacterial count from skin swabs
Time frame: Immediately post-surgery
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 29 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing iodophor-impregnated adhesive drapes and No adhesive drapes in people with Surgical Wound Infection, run by Rothman Institute Orthopaedics.
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 2 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
bacterial count from skin swabs (time frame: Immediately post-surgery). 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 29 Sep 2016.