Hernia, Ventral
Conditions
Keywords
use of mesh
Brief summary
The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.
Detailed description
The study is intended to evaluate the post-operative complications and re-herniations following the use of OviTex® Permanent 1S reinforced bioscaffold in subjects with ventral hernias. The study is designed to mirror surgical standard of care for ventral hernia intervention, with the exception of asking for subjects to return for evaluation at longer time points post-surgery than is typical for standard care. A baseline visit will be performed for patients who are identified for and provide informed consent to participate in the study. During this visit, a review of medical history, a physical exam and assessment of the hernia site will be performed. The potential subject will also be asked to complete two quality of life surveys; one that is disease specific and one that is a standard method of health assessment. On the day of surgery, the ventral hernia will be repaired with the use of OviTex® 1S reinforced bioscaffold. Perioperative data will be collected and the surgeon will provide an assessment of the product's handling qualities. During the course of the hospital stay, the subject will be assessed for incidence of early post-operative surgical site wound events and complications, all necessary medical interventions and/or re-operations. On the day of discharge, surgical site occurrences or wound related events noted at the hernia repair site and the occurrence of other post-operative complications will be assessed. The Day 30 and Day 90 visits will have a visit window of +/- 2 weeks. At these visits, the incidence of late surgical site occurrences or wound related events noted at the hernia repair site will be assessed. If hernia recurrence is suspected, it will be confirmed via diagnostic imaging with a CT scan. The occurrence of other late post-operative complications will also be assessed. The subjects will be asked to complete the same disease specific questionnaire and the same health assessment questionnaire as was done at the Baseline visit, however the subject will also be asked to complete a pain assessment. Both the surgeon and the subject will provide an assessment of his/her satisfaction with the hernia repair. The activities at Months 12 and 24 mirror those of Days 30 and 90, however the visit window is extended to +/- 4 weeks.
Interventions
DEVICEOviTex 1S Permanent
OviTex 1S Permanent is a reinforced tissue matrix consisting of layers of extra-cellular matrix derived from sheep stomachs. The layers are embroidered together with a monofilament polypropylene. One side of the mesh has blue polypropylene stitching, which provides a surface conducive to native tissue growth. The other side of the mesh is a smooth surface intended to minimize tissue attachment (adhesions).
Sponsors
Tela Bio Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject suffers from an uncomplicated ventral hernia that requires surgical repair (open, laparoscopic, or robotic) with the use of an implant to reinforce or replace weakened or missing tissue. * The size of the implant needed for repair is expected to be 18 x 22 cm, 20 x 20 cm or less. * Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria * Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study. * Subject is able to complete Quality of Life (QoL) and pain Questionnaires. * Subject is at least 18 years old (or considered an adult per state law). * Subject is able to participate fully in, and for the full duration of, the study.
Exclusion criteria
* Subject has a BMI of \> 40. * Subject meets CDC/SSI Wound Classification Class IV(Dirty-Infected) criteria. * Subject is female and is pregnant. * Subject has a life expectancy of \< 2 years making it unlikely that the subject will successfully achieve two-year follow-up. * Subject has recent history of drug or alcohol abuse (in last 3 years). * Subject has an allergy to ovine-derived products. * Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial. * Subject is unable to receive OviTex® Permanent 1S reinforced bioscaffold at the time of surgery. Intra-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Occurrences or Wound-related Events | within the first three months of the ventral hernia repair | The primary endpoints were number of participants experiencing an SSO or wound related event at the hernia repair site and the number of participants experiencing other complications \<90 days after index surgery. These included seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections. Complications such as ileus and bowel obstruction were also recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Overall Cumulative SSOs and Complications (0 - 24 Months) | Secondary outcome measures include the number of participants experiencing a hernia recurrence, post-operative SSO, wound related event at the hernia repair site, and other complications occurring at time points \> 90 days after index surgery. |
| Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point | Baseline through 24 months | Hernia-Related Quality-of-Life Survey (HerQLes) assesses abdominal wall function and impact of ventral hernia repair on quality of life through 12 questions. Responses are graded on a likert scale from 1 to 6, 1=strongly disagree, 2=moderately disagree, 3=slightly disagree, 4=slightly agree, 5=moderately agree, 6=strongly agree. A raw score is calculated by the following formula: 12 question average = (Response to Q1 + Response to Q2 +…+ Response to Q12) / 12 A summary score is calculated by the following formula: HerQLes Summary Score = 120-20\*(12 Question Average) HerQLes scores range from 0 (worst possible response) to 100 (best possible response). Data is reported as change in HerQLes Summary Score from baseline to each time point The scale was first reported in Krpata, D. M. et al. Design and Initial Implementation of HerQLes: A Hernia-Related Quality-of-Life Survey to Assess Abdominal Wall Function. J Am Coll Surgeons 215, 635-642 (2012). |
| Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point | Baseline through 24 Months | EuroQol 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) is a standardized generic (disease non-specific) quality of life scale measuring how good or bad the patients' health is on their visit date. The patient indicates on the scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine) how their health is with an X and reports the number in a box. Data is reported as change in EQ-5D VAS score from baseline to each time point. |
| Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point | Baseline through 24 Months | EuroQol 5 Dimensions (EQ-5D) is a standardized generic (disease non-specific) quality of life instrument measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are coded from 1 to 5 (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). The levels reported for each dimension create a 5-digit number (i.e. 11111 or 12345) based on patient response. These 5-digit numbers are converted to an index score by special algorithm that is not publicly available. The index value represents the patient's health status, where higher numbers are associated with better outcomes. Data is reported as change in EQ-5D Index value from baseline to each time point. |
Countries
United States
Participant flow
Pre-assignment details
Of 95 patients were consented, 3 did not meet eligibility criteria and were not enrolled. Only 92 patients were enrolled in the study and received OviTex 1S Permanent reinforced tissue matrix during their hernia repair procedure.
Participants by arm
| Arm | Count |
|---|---|
| OviTex Permanent 1S All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix. | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 1 exited due to recurrence and 2 exited due to mesh removal. | 3 |
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | OviTex Permanent 1S |
|---|---|
| Age, Customized Age | 60.42 years STANDARD_DEVIATION 13.13 |
| Body Mass Index | 31 (kg/m^2) STANDARD_DEVIATION 4.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| modified Ventral Hernia Working Group Grade Grade I | 21 Participants |
| modified Ventral Hernia Working Group Grade Grade II | 52 Participants |
| modified Ventral Hernia Working Group Grade Grade III | 19 Participants |
| Operative Approach Laparoscopic | 12 Participants |
| Operative Approach Open | 60 Participants |
| Operative Approach Robotic | 20 Participants |
| Plane of Placement Intraperitoneal | 42 Participants |
| Plane of Placement Onlay | 1 Participants |
| Plane of Placement Retrofascial/Pre-Periotneal | 1 Participants |
| Plane of Placement Retrorectus/TAR | 48 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 88 Participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 37 Participants |
| Surgical Site Wound Classification CDC Class I Clean | 74 Participants |
| Surgical Site Wound Classification CDC Class II Clean-Contaminated | 14 Participants |
| Surgical Site Wound Classification CDC Class III Contaminated | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 92 |
| other Total, other adverse events | 24 / 92 |
| serious Total, serious adverse events | 34 / 92 |
Outcome results
Primary
Surgical Site Occurrences or Wound-related Events
The primary endpoints were number of participants experiencing an SSO or wound related event at the hernia repair site and the number of participants experiencing other complications \<90 days after index surgery. These included seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections. Complications such as ileus and bowel obstruction were also recorded.
Time frame: within the first three months of the ventral hernia repair
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Mesh Removal (Full) | 1 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Mesh Removal (Partial) | 1 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Superficial Infection | 9 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Deep/Abscess Infection | 6 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Adjacent Recurrence | 0 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Seroma | 10 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Seroma (requiring intervention) | 3 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Hematoma | 4 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Wound Dehiscence | 1 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Skin Necrosis | 1 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Fistulae | 2 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Surgical Site Infection | 15 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Bowel Obstruction | 1 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Ileus | 8 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Any other non-surgery or hernia-related complications | 1 Participants |
| OviTex 1S Permanent | Surgical Site Occurrences or Wound-related Events | Organ Space Infection | 0 Participants |
Secondary
Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point
EuroQol 5 Dimensions (EQ-5D) is a standardized generic (disease non-specific) quality of life instrument measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are coded from 1 to 5 (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). The levels reported for each dimension create a 5-digit number (i.e. 11111 or 12345) based on patient response. These 5-digit numbers are converted to an index score by special algorithm that is not publicly available. The index value represents the patient's health status, where higher numbers are associated with better outcomes. Data is reported as change in EQ-5D Index value from baseline to each time point.
Time frame: Baseline through 24 Months
Population: The number of participants at each time point differs from the overall number of participants analyzed (92) as not all participants completed the required questionnaires at each time point and therefore, only the questionnaires that were available to be analyzed are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OviTex 1S Permanent | Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point | Day 90 | 0.006 scores on a scale | Standard Deviation 0.164 |
| OviTex 1S Permanent | Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point | Month 12 | 0.046 scores on a scale | Standard Deviation 0.142 |
| OviTex 1S Permanent | Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point | Day 30 | -0.048 scores on a scale | Standard Deviation 0.15 |
| OviTex 1S Permanent | Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point | Month 24 | 0.042 scores on a scale | Standard Deviation 0.129 |
Secondary
Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point
EuroQol 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) is a standardized generic (disease non-specific) quality of life scale measuring how good or bad the patients' health is on their visit date. The patient indicates on the scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine) how their health is with an X and reports the number in a box. Data is reported as change in EQ-5D VAS score from baseline to each time point.
Time frame: Baseline through 24 Months
Population: The number of participants at each time point differs from the overall number of participants analyzed (92) as not all participants completed the required questionnaires at each time point and therefore, only the questionnaires that were available to be analyzed are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OviTex 1S Permanent | Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point | Day 30 | -0.05 scores on a scale | Standard Deviation 19.49 |
| OviTex 1S Permanent | Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point | Day 90 | 0.49 scores on a scale | Standard Deviation 21.21 |
| OviTex 1S Permanent | Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point | Month 12 | 6.70 scores on a scale | Standard Deviation 20.48 |
| OviTex 1S Permanent | Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point | Month 24 | 5.28 scores on a scale | Standard Deviation 18.97 |
Secondary
Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point
Hernia-Related Quality-of-Life Survey (HerQLes) assesses abdominal wall function and impact of ventral hernia repair on quality of life through 12 questions. Responses are graded on a likert scale from 1 to 6, 1=strongly disagree, 2=moderately disagree, 3=slightly disagree, 4=slightly agree, 5=moderately agree, 6=strongly agree. A raw score is calculated by the following formula: 12 question average = (Response to Q1 + Response to Q2 +…+ Response to Q12) / 12 A summary score is calculated by the following formula: HerQLes Summary Score = 120-20\*(12 Question Average) HerQLes scores range from 0 (worst possible response) to 100 (best possible response). Data is reported as change in HerQLes Summary Score from baseline to each time point The scale was first reported in Krpata, D. M. et al. Design and Initial Implementation of HerQLes: A Hernia-Related Quality-of-Life Survey to Assess Abdominal Wall Function. J Am Coll Surgeons 215, 635-642 (2012).
Time frame: Baseline through 24 months
Population: The number of participants at each time point differs from the overall number of participants analyzed (92) as not all participants completed the required questionnaires at each time point and therefore, only the questionnaires that were available to be analyzed are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OviTex 1S Permanent | Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point | Day 30 | -5.67 scores on a scale | Standard Deviation 31.62 |
| OviTex 1S Permanent | Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point | Day 90 | 16.25 scores on a scale | Standard Deviation 31.12 |
| OviTex 1S Permanent | Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point | Month 24 | 26.93 scores on a scale | Standard Deviation 29.01 |
| OviTex 1S Permanent | Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point | Month 12 | 25.03 scores on a scale | Standard Deviation 30.09 |
Secondary
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery
Secondary outcome measures include the number of participants experiencing a hernia recurrence, post-operative SSO, wound related event at the hernia repair site, and other complications occurring at time points \> 90 days after index surgery.
Time frame: Overall Cumulative SSOs and Complications (0 - 24 Months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Adjacent Recurrence | 3 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Seroma | 12 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Seroma (requiring intervention) | 3 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Hematoma | 4 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Wound Dehiscence | 1 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Skin Necrosis | 1 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Fistulae | 2 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | SSI | 19 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Bowel Obstruction | 1 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Ileus | 8 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Any other non-surgery or hernia-related complication | 2 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Mesh removal (full) | 2 Participants |
| OviTex 1S Permanent | Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery | Mesh removal (partial) | 1 Participants |