Ventral HerniaNCT01961687
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
A study testing Resorbable Mesh in people with Ventral Hernia and Incisional Hernia, run by C. R. Bard at 16 sites in United States.
Trial summary
Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Incisional Hernia
- What is being tested?
- Resorbable Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 16 sitesUnited States
- Study dates
- Sep 2013to 27 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must have met all of the criteria listed below to be enrolled in the study:
- 1. Subject must have been 18 years of age or older 2. Subject or subject's legally authorized representative must have given written informed consent 3. Subject must have been diagnosed with primary ventral, incisional hernia or first time recurrent ventral or incisional hernia (protocol version 1.4) 3. Subject must be diagnosed with primary ventral, incisional hernia or multiply-recurrent (not to exceed 3 recurrences) ventral or incisional hernia (protocol version 2.0) 4. Subject must have had a hernia greater than 10 cm2 and ≤350 cm2 5. Subject must have been willing to undergo initial ventral, incisional or first recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 1.4) 5. Subject must be willing to undergo initial ventral, incisional or multiply-recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 2.0) 6. Subject met the criteria for a Class I wound as defined by the CDC (Appendix 4 of the protocol) 7. Subjects must have had 1 or more of the following pre-study conditions:
- Body Mass Index (BMI) between 30-40 kg/m2, inclusive
- Active smokers (if attempts to quit smoking within two weeks of surgery have failed and the patient was still an active smoker at the time of surgery)
- COPD presence on patient self-report
- Diabetes mellitus
Show all 12Show fewer
- Immunosuppression
- Coronary Artery Disease
- Chronic corticosteroid use: greater than 6 months systemic use
- Serum albumin less than 3.4 g/dL
- Advanced age: 75 years or older
- Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL
Who cannot join
- Subjects were excluded from study enrollment if any of the following criteria were met:
- 1. Subject's hernia had recurred more than once (protocol version 1.4)
- Subject has had 4 or more previous hernia repairs (of the index hernia) (protocol version 2.0)
- The subject had peritonitis
- The subject was on or suspected to be placed on chemotherapy medications during any part of the study
- The subject's Body Mass Index (BMI) was greater than 40 kg/m2
Show all 19Show fewer
- The subject had cirrhosis of the liver and/or ascites
- Subject was American Society of Anesthesiology Class 4 or 5
- Subject was known to be infected with human immunodeficiency virus (HIV)
- Subject had a life expectancy of less than 2 years at the time of enrollment
- Subject had any condition that, in the opinion of the Investigator, precluded the use of the study device, precluded the subject from completing the follow-up requirements
- Subject's hernia repair utilized intraabdominal mesh placement
- Subject had a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated) as defined by the CDC (Appendix 4 of the protocol)
- Subject had an active or latent systemic infection
- Subject required surgical bridge repair as the sole repair
- Subject was pregnant or had plans to become pregnant during the study period or was breastfeeding
- Subject had enrolled in another clinical study within the last 30 days
- Subject was part of the site personnel directly involved with this study
- Subject had a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate were avoided).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Florida Hospital/Celebration Health
Celebration, Florida, 34747
NorthShore University HealthSystem
Evanston, Illinois, 60201
Univerity of Tennessee Health Science Center
Germantown, Tennessee, 38163
Indiana University
Indianapolis, Indiana, 46202
University of Tennessee Health Sciences Center
Knoxville, Tennessee, 37996
University of Kentucky Medical Center
Lexington, Kentucky, 40506
University of Wisconsin System
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Methodist Health System
Omaha, Nebraska, 68114
Oregon Health and Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23219
University of California, San Diego
San Diego, California, 92103
Baystate Medical Center
Springfield, Massachusetts, 01199
Southeast Area Health and Education Center
Wilmington, North Carolina, 28403
University of Massachusetts Worcester
Worcester, Massachusetts, 01655
About this study
Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.
Read the detailed description
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
- Conditions
- Ventral Hernia, Incisional Hernia
- Being tested
- Resorbable Mesh
- 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.
Resorbable MeshDevice
Phasix Mesh
| Study group | Role | What they receive |
|---|---|---|
| Resorbable Mesh | Other | Phasix Mesh Receives: Device: Resorbable Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence Rate
Hernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
Measured: 60 Months
Surgical Site Infections
Infections at the surgical site will be assessed by physical examination at each study visit through 60 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial and deep surgical site infections
Measured: 60 Months
Secondary outcomes (7)
Pain Visual Analog Scale
Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 60-month follow up. Scores are measured on a scale from 0.0 to 10.0 centimeters and marked on a line by the subject; lower values correspond with low pain perception. The outcome measure is presented as the mean of the absolute difference between the pain perception at Baseline and the pain perception at 60-month follow up. A negative score means a decrease in pain perception.
Measured: 60 Months
Device Related Adverse Events
Incidence of device related adverse events: number of subjects with one or more possibly or definitely device related adverse events. The term "incidence" is an error and is reported here as the rate of device related adverse events.
Measured: 60 Months
Rate of Re-operation Due to the Index Hernia Repair
Rate of re-operation due to the index hernia repair; the proportion of subjects with post-procedure re-operation due do the index hernia repair.
Measured: 60 Months
Carolinas Comfort Scale® (CCS)
Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is a summation of scores across the domains. Therefore, the Total CCS Score ranges from 0-115 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties.
Absolute values of the Total CCS Score at 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, 12-Month follow-up, 18-Month follow up, at 24-Month follow-up, 36-Month follow-up, 48-Month follow-up, and 60-Month follow-up are reported.
The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results.
Measured: 60 Months
SF-12 Questionnaire
The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: 60 Months
Surgical Procedure Time as Measured From Incision to Closure
Surgical procedure time as measured from incision to closure (skin to skin)
Measured: 1 day
Length of Hospital Stay
Time in days from hospital admission to discharge
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startSep 2013
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Scott Roth, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961687
- Sponsor's protocol ID
- DVL-HE-011
- Status last verified
- Jan 2021
- First submitted
- 10 Oct 2013
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roth JS, Anthone GJ, Selzer DJ, Poulose BK, Pierce RA, Bittner JG, Hope WW, Dunn RM, Martindale RG, Goldblatt MI, Earle DB, Romanelli JR, Mancini GJ, Greenberg JA, Linn JG, Parra-Davila E, Sandler BJ, Deeken CR, Badhwar A, Salluzzo JL, Voeller GR. Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up. J Am Coll Surg. 2022 Dec 1;235(6):894-904. doi: 10.1097/XCS.0000000000000363. Epub 2022 Nov 15.
PubMed 36102523
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
- ClinicalTrials.gov ID
- NCT01961687
- Acronym / sponsor ID
- DVL-HE-011
- Conditions
- Ventral Hernia, Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- Sep 2013 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Posted 26 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.
Detailed description
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resorbable Mesh | Other | Device: Resorbable MeshPhasix Mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Subject must have been 18 years of age or older 2. Subject or subject's legally authorized representative must have given written informed consent 3. Subject must have been diagnosed with primary ventral, incisional hernia or first time recurrent ventral or incisional hernia (protocol version 1.4) 3. Subject must be diagnosed with primary ventral, incisional hernia or multiply-recurrent (not to exceed 3 recurrences) ventral or incisional hernia (protocol version 2.0) 4. Subject must have had a hernia greater than 10 cm2 and ≤350 cm2 5. Subject must have been willing to undergo initial ventral, incisional or first recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 1.4) 5. Subject must be willing to undergo initial ventral, incisional or multiply-recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 2.0) 6. Subject met the criteria for a Class I wound as defined by the CDC (Appendix 4 of the protocol) 7. Subjects must have had 1 or more of the following pre-study conditions:
- Body Mass Index (BMI) between 30-40 kg/m2, inclusive
- Active smokers (if attempts to quit smoking within two weeks of surgery have failed and the patient was still an active smoker at the time of surgery)
- COPD presence on patient self-report
- Diabetes mellitus
Key exclusion criteria (19 listed)
- 1. Subject's hernia had recurred more than once (protocol version 1.4)
- Subject has had 4 or more previous hernia repairs (of the index hernia) (protocol version 2.0)
- The subject had peritonitis
- The subject was on or suspected to be placed on chemotherapy medications during any part of the study
- The subject's Body Mass Index (BMI) was greater than 40 kg/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 |
|---|---|---|
| Resorbable MeshPhasix Mesh | Device | Resorbable Mesh |
Primary outcome
Hernia Recurrence Rate
Time frame: 60 Months
Hernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
Surgical Site Infections
Time frame: 60 Months
Infections at the surgical site will be assessed by physical examination at each study visit through 60 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial and deep surgical site infections
7 secondary outcomes
Pain Visual Analog Scale
Time frame: 60 Months
Device Related Adverse Events
Time frame: 60 Months
Rate of Re-operation Due to the Index Hernia Repair
Time frame: 60 Months
Carolinas Comfort Scale® (CCS)
Time frame: 60 Months
SF-12 Questionnaire
Time frame: 60 Months
Surgical Procedure Time as Measured From Incision to Closure
Time frame: 1 day
Length of Hospital Stay
Time frame: 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36102523Roth JS, Anthone GJ, Selzer DJ, Poulose BK, Pierce RA, Bittner JG, Hope WW, Dunn RM, Martindale RG, Goldblatt MI, Earle DB, Romanelli JR, Mancini GJ, Greenberg JA, Linn JG, Parra-Davila E, Sandler BJ, Deeken CR, Badhwar A, Salluzzo JL, Voeller GR. Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up. J Am Coll Surg. 2022 Dec 1;235(6):894-904. doi: 10.1097/XCS.0000000000000363. Epub 2022 Nov 15.
- 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.
Scott Roth, MD principal investigator
University of Kentucky
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resorbable Mesh in people with Ventral Hernia and Incisional Hernia, run by C. R. Bard at 16 sites in United States.
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 12 inclusion and 19 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 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hernia Recurrence Rate (time frame: 60 Months). 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?
On the ClinicalTrials.gov record for NCT01961687, 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 26 Jan 2021.