Ventral HerniaAMEXNCT02401334
Antimicrobial Hernia Repair Device Clinical Study
A study testing Cook® Antimicrobial Hernia Repair Device in people with Ventral Hernia and Incisional Hernia, run by Cook Group Incorporated at 4 sites in 2 countries.
Trial summary
This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV)… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ventral Hernia, Incisional Hernia
- What is being tested?
- Cook® Antimicrobial Hernia Repair Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2015to 25 Jan 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique
Who cannot join
- Body Mass Index (BMI) < 25.
- Body weight < 45 kg
- Glycosylated Hemoglobin (Hgb A1c) > 10%
- Albumin < 2.5 g/dL or pre-albumin < 5.0 mg/dL
- Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2
- Known allergies to study device components
- Other relevant exclusion criteria apply
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada2 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
United Kingdom2 sites
Royal Liverpool Hospital
Liverpool, L7 8XP
Salford Royal Hospital
Salford, England, M68HD
About this study
Official title: Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.
- Conditions
- Ventral Hernia, Incisional Hernia
- Being tested
- Cook® Antimicrobial Hernia Repair Device
- Medical subject headings
- Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook® Antimicrobial Hernia Repair DeviceDevice
Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected
| Study group | Role | What they receive |
|---|---|---|
| Hernia Repair | Experimental | Surgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device. Receives: Device: Cook® Antimicrobial Hernia Repair Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection
Measured: 6 months
Secondary outcomes (1)
Incidence of procedural or post-operative adverse events related to the study device or procedure (i.e., Permanence of hernia repair, as determined by hernia recurrence).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startJun 2015
- Primary completion25 Jan 2018
- Study completion25 Jan 2018
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 Ventral HerniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401334
- Sponsor's protocol ID
- 13-10
- Acronym
- AMEX
- Status last verified
- Feb 2018
- First submitted
- 24 Mar 2015
- Last updated
- 15 Feb 2018
- Results posted
- No
Publications
Minor S, Brown CJ, Rooney PS, Hodde JP, Julien L, Scott TM, Karimuddin AA, Raval MJ, Phang PT. Single-stage repair of contaminated hernias using a novel antibiotic-impregnated biologic porcine submucosa tissue matrix. BMC Surg. 2020 Mar 30;20(1):58. doi: 10.1186/s12893-020-00715-w.
PubMed 32228664
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
- ClinicalTrials.gov ID
- NCT02401334
- Acronym / sponsor ID
- AMEX / 13-10
- Conditions
- Ventral Hernia, Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 27 Mar 2015 (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 prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hernia Repair | Experimental | Device: Cook® Antimicrobial Hernia Repair DeviceSurgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique
Key exclusion criteria (7 listed)
- Body Mass Index (BMI) < 25.
- Body weight < 45 kg
- Glycosylated Hemoglobin (Hgb A1c) > 10%
- Albumin < 2.5 g/dL or pre-albumin < 5.0 mg/dL
- Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2
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 |
|---|---|---|
| Cook® Antimicrobial Hernia Repair DeviceDevice containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected | Device | Hernia Repair |
Primary outcome
Incidence of Surgical Site Infection
Time frame: 6 months
1 secondary outcome
Incidence of procedural or post-operative adverse events related to the study device or procedure (i.e., Permanence of hernia repair, as determined by hernia recurrence).
Time frame: 12 months
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 15 Feb 2018.
- Derived from this study: PubMed 32228664Minor S, Brown CJ, Rooney PS, Hodde JP, Julien L, Scott TM, Karimuddin AA, Raval MJ, Phang PT. Single-stage repair of contaminated hernias using a novel antibiotic-impregnated biologic porcine submucosa tissue matrix. BMC Surg. 2020 Mar 30;20(1):58. doi: 10.1186/s12893-020-00715-w.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook® Antimicrobial Hernia Repair Device in people with Ventral Hernia and Incisional Hernia, run by Cook Group Incorporated at 4 sites in 2 countries.
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 7 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United Kingdom. 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?
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?
Incidence of Surgical Site Infection (time frame: 6 months). 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 NCT02401334, 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 15 Feb 2018.