Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.
This is a post-market, on-label study to understand the performance of the graft in the US.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xen Matrix AB | Experimental | Subjects treated with Xen Matrix AB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xen Matrix AB | Device | Xen Matrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed dry for use in the reconstruction of soft tissue deficiencies. The device surfaces are coated with the antibacterial agents Rifampin and Minocycline in a bioresorbable L-Tyrosine succinate polymer carrier. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Wound Occurrences Up to 45 Days Post Implantation | Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention. | Up to 45 days post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Wound Occurrences > 45 Days Post Implantation | Wound occurrences was defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention. | Day 45 and up to 2 years post implantation |
| Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Martindale, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Hospital of USC | Los Angeles | California | 90033 | United States | ||
| California Pacific Medical Center - Sutter Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Treated With Xen Matrix AB | This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Treated With XenMatrix AB | This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB. |
| 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 Wound Occurrences Up to 45 Days Post Implantation | Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention. | The primary endpoint was wound occurrence within 45 days post implantation that required intervention. | Posted | Count of Participants | Participants | Up to 45 days post implantation |
|
From Day of index procedure up to 24 months post implantation procedure.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Treated With Xen Matrix AB | This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Heimer | Becton Dickinson and Company | +1-401-825-8681 | Dawn.Heimer@bd.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2018 | Aug 25, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2018 | Aug 24, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Within 6 months and 24 months of implantation procedure |
| Number of Participants With Reoperation Due to Index Hernia Repair | 24 months post implantation procedure |
| Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | The Carolinas Comfort Scale (CCS) quality of life questionnaire aimed for patients who have had hernia repair surgery. Symptoms in the CCS are rated by the participants on a scale of 0 to 5, with a score of 0 suggesting no symptoms and a score of 5, disabling symptoms. A lower score on the questionnaire compared to baseline would indicate a better outcome. | Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedure |
| General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | The Short Form 12 (SF-12) is a self-reported 12-item questionnaire that evaluates general health and well-being (overall quality of life of an individual). The SF-12 includes questions on physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating better levels of functioning. | Baseline, 1, 3, 6, 12, 18, and 24 months post implantation |
| Number of Participants Who Returned to Work Post Implantation Procedure | Up to 2 years following implantation procedure |
| Duration of Participants Stay in Hospital Following Implantation Procedure | From index procedure day to discharge from hospital day |
| San Francisco |
| California |
| 94107 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University | St Louis | Missouri | 63108 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Trustees of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79430 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Wound Occurrences > 45 Days Post Implantation | Wound occurrences was defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention. | Posted | Count of Participants | Participants | Day 45 and up to 2 years post implantation |
|
|
|
| Secondary | Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure | Posted | Count of Participants | Participants | Within 6 months and 24 months of implantation procedure |
|
|
|
| Secondary | Number of Participants With Reoperation Due to Index Hernia Repair | Posted | Count of Participants | Participants | 24 months post implantation procedure |
|
|
|
| Secondary | Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | The Carolinas Comfort Scale (CCS) quality of life questionnaire aimed for patients who have had hernia repair surgery. Symptoms in the CCS are rated by the participants on a scale of 0 to 5, with a score of 0 suggesting no symptoms and a score of 5, disabling symptoms. A lower score on the questionnaire compared to baseline would indicate a better outcome. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedure |
|
|
|
| Secondary | General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | The Short Form 12 (SF-12) is a self-reported 12-item questionnaire that evaluates general health and well-being (overall quality of life of an individual). The SF-12 includes questions on physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating better levels of functioning. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 3, 6, 12, 18, and 24 months post implantation |
|
|
|
| Secondary | Number of Participants Who Returned to Work Post Implantation Procedure | The overall number of participants (21) for this endpoint reflects the number of participants who were employed at baseline. | Posted | Count of Participants | Participants | Up to 2 years following implantation procedure |
|
|
|
| Secondary | Duration of Participants Stay in Hospital Following Implantation Procedure | Posted | Mean | Standard Deviation | Days | From index procedure day to discharge from hospital day |
|
|
|
| 1 |
| 75 |
| 31 |
| 75 |
| 55 |
| 75 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Haematoma infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Incision site infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Iatrogenic injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Pancreatic leak | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Skin lesion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Incision site cellulitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Incision site infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Anemia postoperative | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Iatronic injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
The publication of the principal results from any single-center experience within the study is not allowed until the preparation and publication of the multi-center results.
| D010335 | Pathologic Processes |
|
| 3 months |
|
|
| 6 months |
|
|
| 12 months |
|
|
| 18 months |
|
|
| 24 months |
|
|
|
| 3 months |
|
|
| 6 months |
|
|
| 12 months |
|
|
| 18 months |
|
|
| 24 months |
|
|