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Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.
Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zip Surgical Skin Closure | Active Comparator | Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples. |
|
| Steel Staples | Active Comparator | Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zip Surgical Skin Closure | Device | Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incision Appearance / Scar Cosmesis | Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating. | 6-8 weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Closure Method Satisfaction | Closure method satisfaction will be collected by a 5 point satisfaction scale:
| 6-8 weeks post op |
| Patient Pain - Incisional and General |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodney Benner, MD | Study Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shelbourne Knee Center | Indianapolis | Indiana | 46202 | United States |
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This is a split person study where one knee is assigned Zip, the other knee is assigned Staples. 50 knees were closed on 25 participants.
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure. Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair. Steel Staples: Skin closure device for the closure of the skin layer following surgical incision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples. Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair. Steel Staples: Skin closure device for the closure of the skin layer following surgical incision. |
| 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, 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 | Incision Appearance / Scar Cosmesis | Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating. | Posted | Mean | Standard Deviation | units on a scale | 6-8 weeks post surgery |
|
Up to Study Exit at 6 to 8 Week Follow Up
No Serious Adverse Events No All Cause Mortality
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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 | Zip Surgical Skin Closure | Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples. Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair. Steel Staples: Skin closure device for the closure of the skin layer following surgical incision. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial Skin Peeling | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Superficial skin peeling upon device removal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Winters, Clinical Project Manager | ZipLine Medical | 408-506-1866 | wwinters0@gmail.com |
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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 | Apr 21, 2015 | Nov 26, 2018 | Prot_SAP_000.pdf |
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| Steel Staples | Device | Skin closure device for the closure of the skin layer following surgical incision |
|
|
Pain levels will be collected using a 10 point VAS scale. |
| Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit) |
| Surgeon and Patient Scar Satisfaction | Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale: Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied | 6 to 8 wk follow up visit |
| Range of Motion | Knee Range of Motion for each knee will be measured in degrees | 2 weeks and 6-8 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Range of Motion | Range of Motion for each knee will be measured (Left and Right) | Mean | Standard Deviation | degrees |
|
| OG001 |
| Steel Staples |
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure. Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair. Steel Staples: Skin closure device for the closure of the skin layer following surgical incision. |
|
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| Secondary | Surgeon Closure Method Satisfaction | Closure method satisfaction will be collected by a 5 point satisfaction scale:
| Posted | Count of Participants | Participants | 6-8 weeks post op |
|
|
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| Secondary | Patient Pain - Incisional and General | Pain levels will be collected using a 10 point VAS scale. | Patient incisional pain scores for Zip side and incisional pain scores for Staples side were collected (0=no pain, 10=worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit) |
|
|
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| Secondary | Surgeon and Patient Scar Satisfaction | Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale: Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied | Posted | Count of Participants | Participants | 6 to 8 wk follow up visit |
|
|
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| Secondary | Range of Motion | Knee Range of Motion for each knee will be measured in degrees | Posted | Mean | Standard Deviation | degrees | 2 weeks and 6-8 weeks | knees | knees |
|
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|
| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | Steel Staples | Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure. Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair. Steel Staples: Skin closure device for the closure of the skin layer following surgical incision. | 0 | 25 | 0 | 25 | 0 | 25 |
|
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| Surgeon Neither Satisfied or Dissatisfied |
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| 2 Week Pain post removal |
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| 6 to 8 Week Pain |
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| Neither |
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| Dissatisfied |
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| Very Dissatisfied |
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| Patient Scar Satisfaction |
|