Patients Undergoing Open Hernia RepairPhase 2/3NCT01860469
Reducing Mesh Infections in Open Hernia Repairs
A Phase 2/3 study testing vancomycin-soaked mesh and plain mesh in people with Patients Undergoing Open Hernia Repair and Patients Undergoing Ventral or Inguinal Hernia Repair, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Open Hernia Repair, Patients Undergoing Ventral or Inguinal Hernia Repair
- What is being tested?
- vancomycin-soaked mesh and plain mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Jun 2014
- Phase
- Phase 2/3
- 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
- open ventral or inguinal hernia repair
Who cannot join
- laparoscopic hernia repair
- non ventral or inguinal hernia repairs
Trial locations and contacts
1 site in 1 country.
Canada1 site
Five Hills Health Region
Moose Jaw, Saskatchewan, S6H 1H3
Ali Cadili, MD, FRCSC, 3066940200, alicadili1@gmail.com
Ali Cadili, MD, FRCSc
About this study
Official title: Does Soaking Synthetic Mesh in Vancomycin Solution Reduce Mesh Infections in Open Hernia Repairs?
Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection
- Conditions
- Patients Undergoing Open Hernia Repair, Patients Undergoing Ventral or Inguinal Hernia Repair
- Being tested
- vancomycin-soaked mesh, plain mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycin-soaked meshProcedure or surgery
plain meshProcedure or surgery
Also called non vancomycin-soaked mesh
| Study group | Role | What they receive |
|---|---|---|
| plain mesh | Active comparator | standard practice of using plain mesh (non vancomycin-soaked) for open hernia repair Receives: Procedure: plain mesh |
| vancomycin-soaked mesh | Experimental | use of vancomycin-soaked mesh for open hernia repair Receives: Procedure: vancomycin-soaked mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
mesh infections
Measured: 6 months
Secondary outcomes (2)
hernia recurrence
Measured: 6 months
postoperative seroma formation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Open Hernia RepairStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Cadili, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860469
- Sponsor's protocol ID
- MeshVanco
- Status last verified
- May 2013
- First submitted
- 18 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Soaking Synthetic Mesh in Vancomycin Solution Reduce Mesh Infections in Open Hernia Repairs?
- ClinicalTrials.gov ID
- NCT01860469
- Acronym / sponsor ID
- MeshVanco
- Conditions
- Patients Undergoing Open Hernia Repair, Patients Undergoing Ventral or Inguinal Hernia Repair
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- First posted
- 22 May 2013 (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.
Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plain mesh | Active comparator | Procedure: plain meshstandard practice of using plain mesh (non vancomycin-soaked) for open hernia repair |
| vancomycin-soaked mesh | Experimental | Procedure: vancomycin-soaked meshuse of vancomycin-soaked mesh for open hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- open ventral or inguinal hernia repair
Key exclusion criteria (2 listed)
- laparoscopic hernia repair
- non ventral or inguinal hernia repairs
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 |
|---|---|---|
| vancomycin-soaked mesh | Procedure or surgery | vancomycin-soaked mesh |
| plain meshAlso: non vancomycin-soaked mesh | Procedure or surgery | plain mesh |
Primary outcome
mesh infections
Time frame: 6 months
2 secondary outcomes
hernia recurrence
Time frame: 6 months
postoperative seroma formation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
Related trials for Patients Undergoing Open Hernia Repair
RecruitingObservational study
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Incisional Ventral Hernia
Not yet recruiting
Comparison of Two Plane Blocks Used in Open Ventral Hernia Repair Operations
Ventral Hernia, Postoperative Pain
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 Phase 2/3 study testing vancomycin-soaked mesh and plain mesh in people with Patients Undergoing Open Hernia Repair and Patients Undergoing Ventral or Inguinal Hernia Repair, run by University of Saskatchewan at 1 site in Canada.
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 2 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 22 May 2013. 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 Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mesh infections (time frame: 6 months). 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 22 May 2013.