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This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.
All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past will be contacted and asked to take part in this clinical study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.
Study protocol was amended in June of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the AlloMax Surgical Graft to bridge hernia defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlloMax Surgical Graft Group |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft | A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure. | 9 + Months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft. | Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit. | 9+ Months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.
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| Name | Affiliation | Role |
|---|---|---|
| John S Roth, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States | ||
| Benrus Surgical Associates, Inc |
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From September 2010 through October 2011 a total of 78 subjects were enrolled at 4 study centers in the United States. The fifth site was terminated because subject data could not be source verified.
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| ID | Title | Description |
|---|---|---|
| FG000 | AlloMax Surgical Graft Group | The study group included eligible subjects who underwent hernia repair using the AlloMaxâ„¢ Surgical Graft at least 9 months prior to the start of this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AlloMax Surgical Graft Group |
| 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 Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft | A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure. | All enrolled subjects that could be verified through historical medical record review. | Posted | Number | participants | 9 + Months |
|
|
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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 | AlloMax Surgical Graft Group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) |
Study was designed to use existing data. Limitations include: limited data generalizability given the retrospective, single arm, observational study design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Heimer/Director, Clinical Affairs | C. R. Bard: Davol, Inc. | 401-825-8681 | dawn.heimer@crbard.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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| Procedural Time for AlloMax Surgical Graft Placement. |
Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin). |
| 0 Days |
| City of Saint Peters |
| Missouri |
| 63376 |
| United States |
| Winthrop Surgical Associates, Inc. | Mineola | New York | 11501 | United States |
| Surgical Associates, Inc. | Tulsa | Oklahoma | 74136 | United States |
| Golla Center for Plastic Surgery | Pittsburgh | Pennsylvania | 15238 | United States |
| years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kilograms per square meter |
|
|
| Secondary | Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft. | Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit. | All enrolled subjects that could be verified through historical medical record review. | Posted | Number | complication events | 9+ Months |
|
|
|
| Secondary | Procedural Time for AlloMax Surgical Graft Placement. | Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin). | All enrolled subjects that could be verified through historical medical record review. | Posted | Mean | Standard Deviation | minutes | 0 Days |
|
|
|
| 50 |
| 78 |
| 46 |
| 78 |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (12.0) |
|
| Abdominal compartment syndrome | Gastrointestinal disorders | MedDRA (12.0) |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (12.0) |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) |
|
| Ileus | Gastrointestinal disorders | MedDRA (12.0) |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (12.0) |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA (12.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) |
|
| Short-bowel syndrome | Gastrointestinal disorders | MedDRA (12.0) |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (12.0) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) |
|
| Fatigue | General disorders | MedDRA (12.0) |
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| Impaired healing | General disorders | MedDRA (12.0) |
|
| Abdominal abscess | Infections and infestations | MedDRA (12.0) |
|
| Abdominal infection | Infections and infestations | MedDRA (12.0) |
|
| Abdominal wall abscess | Infections and infestations | MedDRA (12.0) |
|
| Bacteraemia | Infections and infestations | MedDRA (12.0) |
|
| Cellulitis | Infections and infestations | MedDRA (12.0) |
|
| Clostridial infection | Infections and infestations | MedDRA (12.0) |
|
| Groin infection | Infections and infestations | MedDRA (12.0) |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) |
|
| Postoperative wound infection | Infections and infestations | MedDRA (12.0) |
|
| Wound infection | Infections and infestations | MedDRA (12.0) |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA (12.0) |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Suture related complication | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Culture wound positive | Investigations | MedDRA (12.0) |
|
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (12.0) |
|
| Cystocele | Reproductive system and breast disorders | MedDRA (12.0) |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (12.0) |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Caesaren section | Surgical and medical procedures | MedDRA (12.0) |
|
| Haematoma | Vascular disorders | MedDRA (12.0) |
|
| Epidermolysis | Congenital, familial and genetic disorders | MedDRA (12.0) |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.0) |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (12.0) |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (12.0) |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA (12.0) |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.0) |
|
| Ileus | Gastrointestinal disorders | MedDRA (12.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) |
|
| Peritonitis | Gastrointestinal disorders | MedDRA (12.0) |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA (12.0) |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) |
|
| Pyrexia | General disorders | MedDRA (12.0) |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA (12.0) |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (12.0) |
|
| Abdominal wall abscess | Infections and infestations | MedDRA (12.0) |
|
| Body tinea | Infections and infestations | MedDRA (12.0) |
|
| Cellulitis | Infections and infestations | MedDRA (12.0) |
|
| Postoperative wound infection | Infections and infestations | MedDRA (12.0) |
|
| Sepsis | Infections and infestations | MedDRA (12.0) |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) |
|
| Wound infection | Infections and infestations | MedDRA (12.0) |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA (12.0) |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Post procedural constipation | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Post procedural diarrhoea | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Blood culture positive | Investigations | MedDRA (12.0) |
|
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.0) |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (12.0) |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (12.0) |
|
| Renal failure | Renal and urinary disorders | MedDRA (12.0) |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (12.0) |
|
| Stress urinary incontinence | Renal and urinary disorders | MedDRA (12.0) |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Scar | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Haematoma | Vascular disorders | MedDRA (12.0) |
|
| Lymphoedema | Vascular disorders | MedDRA (12.0) |
|
| Hypotension | Vascular disorders | MedDRA (12.0) |
|
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