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The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.
Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrospective chart review | Device | The retrospective chart review will include the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for achart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and present (90 days prior to the start of data collection). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure | Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure | Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure | 90 days |
| Incidence of Surgical Site Infections (SSIs) Post Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days) | Number of days between the date of the index procedure and the date of the hospital discharge | 90 days |
| Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled |
Inclusion Criteria:
Exclusion Criteria:
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Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection).
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| Name | Affiliation | Role |
|---|---|---|
| Adam Young, MD | Integra LifeSciences Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical Healing Arts Center | Fort Myers | Florida | 33912 | United States |
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29 subjects screened, 1 subject, screened failure. 28 subjects, male and female were enrolled and completed the study.
The retrospective chart review including the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and September 1, 2022 (90 days prior to the start of data collection) started in November 2022 and ended in december 2022. The enrollment occured at a single Surgical center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Device: Retrospective Chart Review | Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subject has undergone abdominal wall reconstruction for a hernia with Integra Gentrix® Surgical Matrix.
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| ID | Title | Description |
|---|---|---|
| BG000 | Device: Retrospective Chart Review | Subject has undergone abdominal wall reconstruction for a hernia with Integra Gentrix® Surgical Matrix. |
| 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 | Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure | Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure | Posted | Count of Participants | Participants | 90 days |
|
|
Retrospective chart review of AEs that occurred between Index Surgery and last follow-up visit up to 14 months
Adverse Event information were collected on any adverse event that the subject experienced between Index Surgery and last follow-up visit up to 14 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 | Device: Retrospective Chart Review | Subject has undergone abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Volvulus of small bowel | Gastrointestinal disorders | MedDRA | Systematic Assessment | Eroded abdominal wall mesh and volvulus of small intestine adhered to the eroded mesh, surgically treatedEroded abdominal wall mesh and volvulus of small intestine adhered to the eroded mesh, surgically treated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal stenosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dennis Adam Young | Integra LifeSciences | 443 766 2569 | dennis.young@integralife.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 11, 2022 | Aug 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2022 | Aug 24, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure |
| 90 days |
| Incidence of Later Post-operative Complications After 90 Days Post Index Procedure | Percentage of subjects with a later post-operative complications after 90 days post index procedure | 1 year |
| Incidence of Hernia Recurrence Confirmed by Clinical Assessment | Percentage of subjects with a hernia recurrence confirmed by clinical assessment | 1 year |
| Incidence of Reoperation Requirement Due to Index Repair | Percentage of subjects with a reoperation requirement due to index repair | 1 year |
Number of subjects who used opioids following the procedure based on the concomitants medication |
| 90 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure | Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Incidence of Surgical Site Infections (SSIs) Post Index Procedure | Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Incidence of Later Post-operative Complications After 90 Days Post Index Procedure | Percentage of subjects with a later post-operative complications after 90 days post index procedure | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Incidence of Hernia Recurrence Confirmed by Clinical Assessment | Percentage of subjects with a hernia recurrence confirmed by clinical assessment | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Incidence of Reoperation Requirement Due to Index Repair | Percentage of subjects with a reoperation requirement due to index repair | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Other Pre-specified | Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days) | Number of days between the date of the index procedure and the date of the hospital discharge | Posted | Mean | Standard Deviation | Days | 90 days |
|
|
|
| Other Pre-specified | Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled | Number of subjects who used opioids following the procedure based on the concomitants medication | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 0 |
| 28 |
| 3 |
| 28 |
| 13 |
| 28 |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Fall originated a different hernia incarcerated abdominal preperitoneal fat pad |
|
| Postoperative adhesion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Admitted in hospital, adhesions released, obstruction resolved. |
|
| Application site haematoma | General disorders | MedDRA | Systematic Assessment |
|
| Instillation site haematoma | General disorders | MedDRA | Systematic Assessment |
|
| Abdominal wall abscess | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Abdominal wall infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Iatrogenic injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Abscess drainage | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
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