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Slow enrollment due to strict eligibility criteria
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Permacol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acellular porcine dermal collagen mesh | Device | porcine mesh for hernia repair/ abdominal wall reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Roth, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States | ||
| Albany Medical College |
One subject was considered a screen failure due to undergoing chemotherapy for an active malignancy within a year prior to the screening visit.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Permacol | acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Permacol | acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 12 months |
|
12-months
All adverse events (AEs) were coded using the Medical Dictionary of Regulatory Activities (MedDRA) Version 12.1. AEs with a definite, possible, or unable to determine relationship are considered to be related to Permacol™ surgical implant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Permacol | acellular porcine dermal collagen mesh: porcine mesh for hernia repair/ abdominal wall reconstruction after removal of infected prosthetic mesh |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment | Considered not related to procedure or device. It was later determined that the event was related to antibiotic medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather McManus | Medtronic | 2038213323 | heather.mcmanus@medtronic.com |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12-month post-procedure change from baseline |
| 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. | Baseline |
| 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. | 12-month post-procedure |
| Albany |
| New York |
| 12208 |
| United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | lb |
|
| Height | Mean | Standard Deviation | inches |
|
| BMI | Mean | Standard Deviation | kg/m² |
|
| Employment Status | Number | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12-month post-procedure change from baseline |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12-month post-procedure |
|
|
|
| 1 |
| 8 |
| 4 |
| 8 |
| 7 |
| 8 |
|
| Tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment | Categorized as possibly related to Permacol™ surgical implant and procedure. The event resolved two days after onset and did not occur again throughout the study. |
|
| Cardiopulmonary Failure | Cardiac disorders | MedDRA 12.1 | Systematic Assessment | Categorized as unknown relation to procedure and no relation to device. |
|
| Left epididymal orchitis with scrotal edema | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment | Categorized as not related to procedure or device and was ongoing at the time of study closure. |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oropharyngeal blistering | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Incontinence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary incontinence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ichthyosis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| General Health |
|
| Social Functioning |
|
| Role Emotional |
|
| Vitality |
|
| Mental Health |
|
| Physical Component Score |
|
| Mental Component Score |
|
| Title | Measurements |
|---|---|
|
| General Health |
|
| Social Functioning |
|
| Role Emotional |
|
| Vitality |
|
| Mental Health |
|
| Physical Component Score |
|
| Mental Component Score |
|
| Title | Measurements |
|---|---|
|
| General Health |
|
| Social Functioning |
|
| Role Emotional |
|
| Vitality |
|
| Mental Health |
|
| Physical Component Score |
|
| Mental Component Score |
|