Hernia
Conditions
Keywords
Hernia, Contaminated Field, Mesh Removal, infected mesh removal
Brief summary
This pilot study is to examine the feasibility of using Permacol Surgical Implant in the repair of abdominal wall defects after removal of infected prosthetic mesh
Interventions
DEVICEacellular porcine dermal collagen mesh
porcine mesh for hernia repair/ abdominal wall reconstruction
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Have given written Informed Consent * Be 18-85 years of age (inclusive) * Have prosthetic mesh that is in proximity to an infected wound that has failed conservative management for at least 3 months, with mesh exposure and a draining wound, or that is in proximity to an abscess that requires operative intervention. * Have a wound characterized by purulent discharge, positive gram stain or positive culture to document infection * Be a candidate for surgical removal of infected mesh placed for repair of ventral/incisional hernias and concomitant abdominal wall reconstruction * Have an ASA Score ≤3 * Have a body mass index (BMI) between 16.5 and 40 inclusive * Be a candidate for anticipated primary approximation of skin/wound * Have a life expectancy of at least 18 months * Be willing to allow biopsy of implant if secondary wound opening is performed or spontaneous implant exposure occurs
Exclusion criteria
* Have loss of abdominal domain such that the operation would be impractical or would adversely effect respiratory or cardiovascular function to an unacceptable degree * Have an enterocutaneous fistula in proximity to wound/mesh * Be a candidate for emergency surgery that would make giving valid Informed Consent impractical * Be currently taking part in another clinical study that conflicts with the current study * Have known allergy to porcine collagen products * Have active generalized peritonitis or intraperitoneal sepsis * Have active necrotizing fasciitis * Have active abdominal compartment syndrome * Have active untreated metabolic or systemic illness * Report unintentional weight loss \>10% of body weight in the previous 90 days * Have known collagen metabolism disorder.(e.g., Ehlers-Danlos syndrome) * Have known altered immune response (e.g., HIV or other immunodeficiency disorder)) * Have chronic renal failure * Have known active malignancy present * Have history of systemic chemotherapy within previous 1 year * Have lifetime history of radiation to the abdomen, pelvis or thorax * Have inguinal or groin hernia as primary diagnosis * Be currently pregnant or planning to become pregnant during study period * Be unable to give valid informed consent or comply with required follow- up schedule * Suffer from mental capacity sufficiently severe to make informed consent unobtainable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening | 12 months | The primary objective of this study was hernia recurrence or surgical site infection as assessed by a CT scan 12 months following surgery.Hernia recurrence was defined as any abnormal abdominal protrusion, as assessed by 12 month CT. Surgical site infection requiring wound opening was defined as abscess formation or drainage that required surgical wound opening. Wound opening was defined as surgical entry into the wound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Having Permacol Implants Removed or Debrided After Implantation | 12 months | The secondary objective of this study was the incidence of Permacol™ surgical implant removal or debridement. Removal was defined as complete surgical excision of the implant. Debridement was defined as debridement or lavage of ≥10% of the visible implant surface area as subjectively assessed by the operating surgeon. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical and Other Examinations | 12-month post-procedure change from baseline | The SF-12v2 Health Survey® (12-question short form health survey) measure eight domains of health related quality of life, which is then aggregated to provide summary measure of the respondent's physical and mental health. Results of 12-month abdominal CT examination are summarized as a change from the baseline. The SF-12v2 Health Survey® is broken into physical health and mental health. Physical health is determined by: physical functioning, role-playing, bodily pain and general health. Mental health is determined by: vitality, social functioning, role-emotional and mental health. The general population mean of the United States is 50. When analyzing the results, the mean values of the study subjects are taken and compared to the general United States population. Each 10 points represent one standard deviation. A measure of one standard deviation (10 points) below the population mean (50) indicates significant function impairment. |
Countries
United States
Participant flow
Recruitment details
Subjects diagnosed with infected prosthetic mesh who were scheduled to undergo planned removal of the mesh were assessed for potential study eligibility. Subjects needed to fulfill all inclusion criteria and no exclusion criteria to be enrolled into the study.
Pre-assignment details
One subject was considered a screen failure due to undergoing chemotherapy for an active malignancy within a year prior to the screening visit.
Participants by arm
| Arm | Count |
|---|---|
| Permacol acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Screen failure | 1 |
| Overall Study | Sponsor terminated study | 1 |
Baseline characteristics
| Characteristic | Permacol |
|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 13.35 |
| BMI | 36.91 kg/m² STANDARD_DEVIATION 7.812 |
| Employment Status Disability/Sick Leave | 4 participants |
| Employment Status Full Time | 2 participants |
| Employment Status Missing | 2 participants |
| Height | 70.0 inches STANDARD_DEVIATION 5.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
| Weight | 253.1 lb STANDARD_DEVIATION 55.92 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 8 |
| other Total, other adverse events | 7 / 8 |
| serious Total, serious adverse events | 4 / 8 |
Outcome results
Primary
Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening
The primary objective of this study was hernia recurrence or surgical site infection as assessed by a CT scan 12 months following surgery.Hernia recurrence was defined as any abnormal abdominal protrusion, as assessed by 12 month CT. Surgical site infection requiring wound opening was defined as abscess formation or drainage that required surgical wound opening. Wound opening was defined as surgical entry into the wound.
Time frame: 12 months
Population: Hernia recurrence and Surgical Site Infection Requiring Wound Opening for one subject could not be assessed due to death unrelated to the study device. The subject died 19 days post-operatively and therefore primary endpoints assessed at 12 month visit were reported as missing.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Permacol | Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening | No Hernia Recurrence or Surgical Site Infection Requiring Wound Opening | 7 Participants |
| Permacol | Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening | Missing | 1 Participants |
Secondary
Subjects Having Permacol Implants Removed or Debrided After Implantation
The secondary objective of this study was the incidence of Permacol™ surgical implant removal or debridement. Removal was defined as complete surgical excision of the implant. Debridement was defined as debridement or lavage of ≥10% of the visible implant surface area as subjectively assessed by the operating surgeon.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Permacol | Subjects Having Permacol Implants Removed or Debrided After Implantation | None Reported | 8 Participants |
| Permacol | Subjects Having Permacol Implants Removed or Debrided After Implantation | Reported | 0 Participants |
Other Pre-specified
Physical and Other Examinations
The SF-12v2 Health Survey® (12-question short form health survey) measure eight domains of health related quality of life, which is then aggregated to provide summary measure of the respondent's physical and mental health. Results of 12-month abdominal CT examination are summarized as a change from the baseline. The SF-12v2 Health Survey® is broken into physical health and mental health. Physical health is determined by: physical functioning, role-playing, bodily pain and general health. Mental health is determined by: vitality, social functioning, role-emotional and mental health. The general population mean of the United States is 50. When analyzing the results, the mean values of the study subjects are taken and compared to the general United States population. Each 10 points represent one standard deviation. A measure of one standard deviation (10 points) below the population mean (50) indicates significant function impairment.
Time frame: 12-month post-procedure change from baseline
Population: At baseline eight subjects completed the questionnaire and at 12 months there were seven subjects who completed the questionnaire due to the death of one patient.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Permacol | Physical and Other Examinations | Physical Functioning | 12.37 score on a scale | Standard Deviation 16.292 |
| Permacol | Physical and Other Examinations | Role Physical | 10.28 score on a scale | Standard Deviation 7.271 |
| Permacol | Physical and Other Examinations | Bodily Pain | 7.73 score on a scale | Standard Deviation 14.194 |
| Permacol | Physical and Other Examinations | General Health | -0.57 score on a scale | Standard Deviation 6.953 |
| Permacol | Physical and Other Examinations | Social Functioning | 8.90 score on a scale | Standard Deviation 10.27 |
| Permacol | Physical and Other Examinations | Role Emotional | 11.14 score on a scale | Standard Deviation 16 |
| Permacol | Physical and Other Examinations | Vitality | 2.81 score on a scale | Standard Deviation 14.715 |
| Permacol | Physical and Other Examinations | Mental Health | 4.92 score on a scale | Standard Deviation 9.027 |
| Permacol | Physical and Other Examinations | Physical Component Score | 7.96 score on a scale | Standard Deviation 10.167 |
| Permacol | Physical and Other Examinations | Mental Component Score | 5.42 score on a scale | Standard Deviation 8.769 |
Other Pre-specified
Physical and Other Examinations
The SF-12v2 Health Survey® (12-question short form health survey) measure eight domains of health related quality of life, which is then aggregated to provide summary measure of the respondent's physical and mental health. Results of 12-month abdominal CT examination are summarized as a change from the baseline. The SF-12v2 Health Survey® is broken into physical health and mental health. Physical health is determined by: physical functioning, role-playing, bodily pain and general health. Mental health is determined by: vitality, social functioning, role-emotional and mental health. The general population mean of the United States is 50. When analyzing the results, the mean values of the study subjects are taken and compared to the general United States population. Each 10 points represent one standard deviation. A measure of one standard deviation (10 points) below the population mean (50) indicates significant function impairment.
Time frame: Baseline
Population: At baseline eight subjects completed the questionnaire and at 12 months there were seven subjects who completed the questionnaire due to the death of one patient.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Permacol | Physical and Other Examinations | Physical Functioning | 37.39 score on a scale | Standard Deviation 10.304 |
| Permacol | Physical and Other Examinations | Role Physical | 37.36 score on a scale | Standard Deviation 7.417 |
| Permacol | Physical and Other Examinations | Bodily Pain | 39.69 score on a scale | Standard Deviation 12.754 |
| Permacol | Physical and Other Examinations | General Health | 44.52 score on a scale | Standard Deviation 13.225 |
| Permacol | Physical and Other Examinations | Social Functioning | 41.34 score on a scale | Standard Deviation 12.352 |
| Permacol | Physical and Other Examinations | Role Emotional | 35.49 score on a scale | Standard Deviation 14.437 |
| Permacol | Physical and Other Examinations | Vitality | 47.84 score on a scale | Standard Deviation 11.075 |
| Permacol | Physical and Other Examinations | Mental Health | 46.28 score on a scale | Standard Deviation 10.814 |
| Permacol | Physical and Other Examinations | Physical Component Score | 39.18 score on a scale | Standard Deviation 8.947 |
| Permacol | Physical and Other Examinations | Mental Component Score | 44.61 score on a scale | Standard Deviation 9.849 |
Other Pre-specified
Physical and Other Examinations
The SF-12v2 Health Survey® (12-question short form health survey) measure eight domains of health related quality of life, which is then aggregated to provide summary measure of the respondent's physical and mental health. Results of 12-month abdominal CT examination are summarized as a change from the baseline. The SF-12v2 Health Survey® is broken into physical health and mental health. Physical health is determined by: physical functioning, role-playing, bodily pain and general health. Mental health is determined by: vitality, social functioning, role-emotional and mental health. The general population mean of the United States is 50. When analyzing the results, the mean values of the study subjects are taken and compared to the general United States population. Each 10 points represent one standard deviation. A measure of one standard deviation (10 points) below the population mean (50) indicates significant function impairment.
Time frame: 12-month post-procedure
Population: At baseline eight subjects completed the questionnaire and at 12 months there were seven subjects who completed the questionnaire due to the death of one patient.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Permacol | Physical and Other Examinations | Physical Functioning | 49.19 score on a scale | Standard Deviation 11.13 |
| Permacol | Physical and Other Examinations | Role Physical | 47.19 score on a scale | Standard Deviation 12.422 |
| Permacol | Physical and Other Examinations | Bodily Pain | 47.42 score on a scale | Standard Deviation 12.134 |
| Permacol | Physical and Other Examinations | General Health | 45.48 score on a scale | Standard Deviation 12.223 |
| Permacol | Physical and Other Examinations | Social Functioning | 50.55 score on a scale | Standard Deviation 9.895 |
| Permacol | Physical and Other Examinations | Role Emotional | 46.63 score on a scale | Standard Deviation 16 |
| Permacol | Physical and Other Examinations | Vitality | 50.47 score on a scale | Standard Deviation 10.514 |
| Permacol | Physical and Other Examinations | Mental Health | 51.92 score on a scale | Standard Deviation 12.581 |
| Permacol | Physical and Other Examinations | Physical Component Score | 46.96 score on a scale | Standard Deviation 7.822 |
| Permacol | Physical and Other Examinations | Mental Component Score | 50.58 score on a scale | Standard Deviation 12.289 |