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The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacolâ„¢ Biological Implant in the treatment of complex abdominal wall defects
This will be a prospective, multi-centre, non-randomized study to collect post-market clinical data on Permacolâ„¢ Biological Implant following complex abdominal wall repair (including abdominal wall defects and fascial dehiscence). The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 6 months, 12 months, 24 months, and 36 months post-surgery.
The study will enroll up to 200 subjects at up to 20 sites. Enrollment is anticipated to take between 18 and 24 months.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery | Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence. | 36 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | Characterize short-term and mid-term outcomes within 24 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence. | 24 months post-surgery |
| QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. |
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Inclusion Criteria:
Subjects who meet all of the following criteria will be eligible for study enrollment:
Exclusion Criteria:
All subjects who meet any of the following criteria should not be enrolled into the study:
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All subjects who will undergo planned surgical treatment for complex abdominal wall repair with Permacolâ„¢ implantation and agree to 36 months of follow-up.
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| Name | Affiliation | Role |
|---|---|---|
| Pasquale Giordano, MD | Whipps Cross University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ St Lucas | Ghent | Belgium | ||||
| CHU Ambroise Pare |
All subjects undergoing planned surgical treatment for complex abdominal wall repair with Permacol implantation and who agree to 36 months of follow-up.
The study allowed inclusion of up to 200 subjects at up to 20 sites.
115 patients were enrolled at 12 sites in 5 European countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Permacol Biological Implant Single Arm | Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Permacol Biological Implant Single Arm | Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study. At the Screening/Baseline (-60 days) the following patient elements are collected:
|
| 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 Undergo Reoperation for Hernia at 36 Months Post-surgery | Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence. | This was the number of respondents at the 36-month follow up visit for this assessment. | Posted | Count of Participants | Participants | 36 months post-surgery |
|
|
Day of surgery, and 6, 12, 24 and 36 months post-surgery.
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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 Biological Implant Single Arm | Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Compartment Syndrome | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea DiScipio, Clinical Research Associate | Medtronic | 781-491-5350 | andrea.l.discipio@medtronic.com |
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| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D000007 | Abdominal Injuries |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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Quality of Life by Carolina's Comfort Scale at 6 months, 12 months, 24 months, and 36 months. The areas of assessment were: Sensation of Mesh, Pain, and Movement Limitations at each of the follow-up time points. Unscheduled surgery is any surgery that is performed outside of the primary study procedure. The scale measurements: 0 = no symptoms; 1 = mild but not bothersome symptoms; 2 = mild and bothersome symptoms; 3 = moderate and/or daily symptoms,;4 = severe symptoms; 5 = disabling symptoms |
| 6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points. |
| Patient Satisfaction Questionnaire - Right Choice to Have Surgery | Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: Was it the right choice to have the surgery? | 6, 12, 24 and 36 months post-surgery |
| Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: How satisfied are you with the outcome of the operation? | 6, 12, 24 and 36 months post-surgery |
| Number of Participants With Post-op Complications | Subject incidence of post-operative complications, specifically: wound infection, seroma, hematoma, wound dehiscence, and fistula. Unscheduled surgery is any surgery that is performed outside of the primary study procedure. | 6, 12, 24 and 36 months post-surgery |
| Mons |
| 7000 |
| Belgium |
| CHU Ambroise Paré | Mons | Belgium |
| Universitätsklinikum des Saarlandes | Homburg | 66424 | Germany |
| RCCS Istituto Clinico Humanitas di Milano | Milan | Italy |
| Istituto Nazionale Tumori | Naples | Italy |
| University Hospital (C/O Istituto Clinica Chirugica II) | Rome | Italy |
| Centre Hospitalier Emile Mayrisch | Esch-sur-Alzette | 4005 | Luxembourg |
| Whipps Cross University Hospital | Leytonstone | London | E11 1NR | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | Wonford | EX2 5DW | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Torbay Hospital | Torquay | TQ2 7AA | United Kingdom |
| Withdrawal by Subject |
|
| Withdrawal by Surgeon |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Subjects who require complex abdominal repair. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Participants |
|
|
| Secondary | Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | Characterize short-term and mid-term outcomes within 24 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence. | Proportion of subjects who underwent reoperation for hernia or hernia recurrence at 24 month post-surgery follow-up. | Posted | Count of Participants | Participants | 24 months post-surgery |
|
|
|
| Secondary | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | Quality of Life by Carolina's Comfort Scale at 6 months, 12 months, 24 months, and 36 months. The areas of assessment were: Sensation of Mesh, Pain, and Movement Limitations at each of the follow-up time points. Unscheduled surgery is any surgery that is performed outside of the primary study procedure. The scale measurements: 0 = no symptoms; 1 = mild but not bothersome symptoms; 2 = mild and bothersome symptoms; 3 = moderate and/or daily symptoms,;4 = severe symptoms; 5 = disabling symptoms | We excluded patients who were not included in this assessment at the 6 - 36 month post-surgery follow-up time points. | Posted | Mean | Standard Deviation | Scores on a scale | 6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points. |
|
|
|
| Secondary | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: Was it the right choice to have the surgery? | This is the number of patients whom were included in this study assessment. | Posted | Count of Participants | Participants | 6, 12, 24 and 36 months post-surgery |
|
|
|
| Secondary | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: How satisfied are you with the outcome of the operation? | This was the number of patients included in this study assessment. | Posted | Count of Participants | Participants | 6, 12, 24 and 36 months post-surgery |
|
|
|
| Secondary | Number of Participants With Post-op Complications | Subject incidence of post-operative complications, specifically: wound infection, seroma, hematoma, wound dehiscence, and fistula. Unscheduled surgery is any surgery that is performed outside of the primary study procedure. | The overall number analyzed is the total number of patients for the study. The number analyzed in each row relates to the number of patients at each visit who had one of these adverse events. | Posted | Count of Participants | Participants | 6, 12, 24 and 36 months post-surgery |
|
|
|
| 8 |
| 115 |
| 93 |
| 115 |
| 41 |
| 115 |
| Abdominal Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Enterocutaneous Fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Faecal Incontinence | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal Fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal Perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Umbilical Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
|
| Allergic Granulomatous Angiitis | Immune system disorders | Systematic Assessment |
|
| Device Related Infection | Infections and infestations | Systematic Assessment |
|
| Device Related Sepsis | Infections and infestations | Systematic Assessment |
|
| Orchitis | Infections and infestations | Systematic Assessment |
|
| Postoperative Wound Infection | Infections and infestations | Systematic Assessment |
|
| Subcutaneous Abscess | Infections and infestations | Systematic Assessment |
|
| Urosepsis | Infections and infestations | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Femoral Neck Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Incisional Hernia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post Procedural Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post Procedural Hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Postoperative Wound Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Brain Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cervix Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Metastatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Squamous Cell Carcinoma of Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Loss of Consciousness | Nervous system disorders | Systematic Assessment |
|
| Subarachnoid Hemorrhage | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | Systematic Assessment |
|
| Substance-Induced Psychotic Disorder | Psychiatric disorders | Systematic Assessment |
|
| Renal Failure Acute | Psychiatric disorders | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Carotid Endarterectomy | Surgical and medical procedures | Systematic Assessment |
|
| Ileostomy | Surgical and medical procedures | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Venous Thrombosis Limb | Vascular disorders | Systematic Assessment |
|
| Recurrence of Hernia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
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| Patients with hernia recurrence requiring surgery |
|
|
| 6-month post surgery: Movement Limitations |
|
|
| 12-month post surgery: Sensation of Mesh |
|
|
| 12-month post surgery: Pain |
|
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| 12-month post surgery: Movement Limitations |
|
|
| 24-month post surgery: Sensation of Mesh |
|
|
| 24-month post surgery: Pain |
|
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| 24-month post surgery: Movement Limitations |
|
|
| 36-month post surgery: Sensation of Mesh |
|
|
| 36-month post surgery: Pain |
|
|
| 36-month post surgery: Movement Limitations |
|
|
| Unscheduled Surgery: Sensation of Mesh |
|
|
| Unscheduled Surgery: Pain |
|
|
| Unscheduled Surgery: Movement Limitations |
|
|
| N/A |
|
| 12-month Visit |
|
|
| 24-month Visit |
|
|
| 36-month Visit |
|
|
| Somewhat Satisfied |
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| Not Satisfied |
|
| 12-month Visit |
|
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| 24-month Visit |
|
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| 36-month Visit |
|
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| Hematoma |
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| Wound dehiscence |
|
| Fistula |
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| At surgery |
|
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| 1-month post surgery |
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| 6-months post surgery |
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| 12-months post surgery |
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| 24-months post surgery |
|
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| 36-months post surgery |
|
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| Unscheduled surgeries |
|
|