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| Name | Class |
|---|---|
| Ludwig Medical Corporation | UNKNOWN |
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This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue
Elevator & Retractor [SISTER] device to assess:
The device, Suction-Integrated Surgical Tissue Elevator & Retractor [SISTER], is shaped like a Cobb elevator but also has a hollow core allowing suction tubing to be connected. Thus, a single hand can be used to retract and suction at the same time while the other hand separates soft tissue from the bones with electrocautery. This set up which is proposed to be more efficient will be evaluated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of Cobb device | Experimental | Use of SISTER device during surgery |
|
| Control | No Intervention | Standard exposure technique and instruments will be used during surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SISTER device | Device | Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss | Amount of blood loss from incision time to screw placement | 1.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Exposure | Length of operation in minutes | 1.5 hours |
| Rate of Clogging | Average number of times the suction tip of the device had to be unclogged |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Cõté, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
There is no plan to share individual participant data (IPD)
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| ID | Title | Description |
|---|---|---|
| FG000 | Use of Cobb Device | Use of SISTER device during surgery SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery |
| FG001 | Control | Standard exposure technique and instruments will be used during surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Use of Cobb Device | Use of SISTER device during surgery SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery |
| BG001 | Control |
| 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 | Estimated Blood Loss | Amount of blood loss from incision time to screw placement | Posted | Mean | Standard Deviation | ml | 1.5 hours |
|
|
1.5 hours
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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 | Use of Cobb Device | Use of SISTER device during surgery SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Cote | University of Miami Miller School of Medicine | 305-256-4492 | Icote@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2017 | Apr 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| 1.5 hours |
Standard exposure technique and instruments will be used during surgery
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Time of Exposure | Length of operation in minutes | Posted | Mean | Standard Deviation | minutes | 1.5 hours |
|
|
|
|
| Secondary | Rate of Clogging | Average number of times the suction tip of the device had to be unclogged | Posted | Mean | Standard Deviation | tip clogs | 1.5 hours |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control | Standard exposure technique and instruments will be used during surgery | 0 | 10 | 0 | 10 | 0 | 10 |
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