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The purpose of this study is to evaluate an investigational sutureless drain securement device (K-Lock) and compare this device to standard drain securement.
This study will evaluate the feasibility, safety and efficacy of a novel sutureless drain securement device (K-Lock) via direct comparison to suture-based techniques. In this study the sutureless drain securement device will be compared to the use of sutures to secure drains. Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A K-Lock left | Experimental | A) left side K-Lock with right side suture-based technique |
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| B K-Lock right | Experimental | B) right side K-Lock with left side suture-based technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-Lock | Device | Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time it Takes to Secure and Dress Each Drain in Totality | Time it takes to secure and dress each drain will be evaluated in totality by evaluation of video recordings to record timestamps and documented on "K-Lock Study Outcomes" tool. This will help determine the feasibility of using this device. | Day of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Use | For each participant, the surgeon will evaluate the K-Lock device ease of use of on a scale from 1-5. A higher score indicates greater ease of use. | Day of Surgery |
| Skin Injury | Skin Injury will be evaluated by inspecting device sites for instances of skin injury at each office visit and will be recorded on "K-Lock Study Outcomes" tool. Skin Injury will also be evaluated by quantitative feedback obtained in the "Drain Securement Survey" given to patients post-operatively. Number of Injuries for all K-Lock sites will be reported as a total. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa David, MD MBA | Wake Forest University Health Sciences | Principal Investigator |
| Adam J Katz, MD | Wake Forest University Health Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | A K-Lock Left | A) left side K-Lock with right side suture-based technique K-Lock: Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique. |
| FG001 | B K-Lock Right | B) right side K-Lock with left side suture-based technique. K-Lock: Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | A K-Lock Left | A) left side K-Lock with right side suture-based technique K-Lock: Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique. |
| BG001 | B K-Lock Right |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Time it Takes to Secure and Dress Each Drain in Totality | Time it takes to secure and dress each drain will be evaluated in totality by evaluation of video recordings to record timestamps and documented on "K-Lock Study Outcomes" tool. This will help determine the feasibility of using this device. | Posted | Mean | Standard Deviation | Seconds | Day of Surgery |
|
3 months
Reported all Adverse Events within 24 hours of becoming aware.
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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 | A K-Lock Left | A) left side K-Lock with right side suture-based technique | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device became loose | Surgical and medical procedures | Systematic Assessment | Patient called the triage nurse to report that the device had become loose. Patient was brought in to be examined and device was removed. Drain was secured with suture. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caleb Suggs | Wake Forest School of Medicine | 3367164171 | csuggs@wakehealth.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 | Nov 9, 2023 | Mar 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2024 | Mar 7, 2025 | ICF_001.pdf |
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Randomized controlled trial
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| On Average Day 10 |
B) right side K-Lock with left side suture-based technique. K-Lock: Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Ease of Use | For each participant, the surgeon will evaluate the K-Lock device ease of use of on a scale from 1-5. A higher score indicates greater ease of use. | Surgeons were assessed for this Outcome Measure but were not enrolled in the study. It was pre-specified to collect and report the scores for the K-Lock device itself, regardless of left or right. Individual surgeons performed surgery on more than one participant which explains why the number of surgeries is higher than the number of surgeons (overall number of participants analyzed). | Posted | Mean | Standard Deviation | score on a scale | Day of Surgery | surgeries | surgeries |
|
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| Secondary | Skin Injury | Skin Injury will be evaluated by inspecting device sites for instances of skin injury at each office visit and will be recorded on "K-Lock Study Outcomes" tool. Skin Injury will also be evaluated by quantitative feedback obtained in the "Drain Securement Survey" given to patients post-operatively. Number of Injuries for all K-Lock sites will be reported as a total. | Posted | Number | Occurrence of skin injury | On Average Day 10 | K-Lock Drain Sites | K-Lock Drain Sites |
|
|
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| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | B K-Lock Right | B) right side K-Lock with left side suture-based technique. | 0 | 9 | 0 | 9 | 1 | 9 |
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| Hematoma | Surgical and medical procedures | Systematic Assessment | Patient taken back to OR for evaluation of a hematoma and the device was removed |
|
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