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A single-center, phase IV, randomized, prospective study investigating the efficacy of various wound closure devices in reducing postoperative wound complications.
The zipper wound technology is a new wound closure device that is an alternative to the commonly used conventional staples and sutures. The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. The other treatment groups include monocryl + Dermabond (conventional sutures and skin adhesive glue) and polyester mesh + Dermabond. All products have been FDA approved. A randomized control trial will provide the highest level of evidence without altering the potential risks to the patient as all three wound closure techniques have been found to have comparable complication rates. The three different treatment devices will be administered following the normal standard of care. All three wound closure devices are currently being used at NYULMC. No modifications to the normal standard of practice other than the randomization process will be implemented. Given the nature of the application of the wound closure device, which will be visible to the surgeon at the time of application and the patient postoperatively, the study will not be blinded to either the surgeon or the patient. Prior to discharge, a blinded plastic surgeon will be asked to assess the wound based on comesis and overall quality of wound healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zipper surgical skin closure | Experimental | Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty |
|
| Monocryl + Dermabond | Active Comparator | Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today. |
|
| Polyester mesh + Dermabond | Active Comparator | The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zipper surgical skin closure | Device | The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line, and this rating is then measured from the left edge. The total range of score is 0-10; the higher the score the worse the pain (0 = no pain, 10 = worst pain imaginable). | 4 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ran Schwarzkopf | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zipper Surgical Skin Closure | Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. |
| FG001 | Monocryl + Dermabond | Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today. Monocryl + Dermabond: conventional sutures and skin adhesive glue |
| FG002 | Polyester Mesh + Dermabond | The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study Polyester mesh + Dermabond: conventional sutures and skin adhesive glue |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zipper Surgical Skin Closure | Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. |
| BG001 |
| 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 | Visual Analog Scale (VAS) for Pain | The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line, and this rating is then measured from the left edge. The total range of score is 0-10; the higher the score the worse the pain (0 = no pain, 10 = worst pain imaginable). | Posted | Mean | Standard Deviation | score on a scale | 4 Days |
|
30 days following the last administration of study treatment
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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 | Zipper Surgical Skin Closure | Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision Surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Drainage | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ran Schwarzkopf, MD | NYU Langone Health | 646-356-9405 | Ran.Schwarzkopf@nyulangone.org |
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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 | Jan 10, 2017 | Aug 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C095495 | glycolide E-caprolactone copolymer |
| C100832 | octyl 2-cyanoacrylate |
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Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty will be compared to two groups: 1) Monocryl + Dermabond 2) Polyester mesh + Dermabond
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| Monocryl + Dermabond | Other | conventional sutures and skin adhesive glue |
|
| Polyester mesh + Dermabond | Other | conventional sutures and skin adhesive glue |
|
| Monocryl + Dermabond |
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today. Monocryl + Dermabond: conventional sutures and skin adhesive glue |
| BG002 | Polyester Mesh + Dermabond | The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study Polyester mesh + Dermabond: conventional sutures and skin adhesive glue |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today. Monocryl + Dermabond: conventional sutures and skin adhesive glue |
| OG002 | Polyester Mesh + Dermabond | The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study Polyester mesh + Dermabond: conventional sutures and skin adhesive glue |
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 2 |
| 53 |
| EG001 | Monocryl + Dermabond | Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today. Monocryl + Dermabond: conventional sutures and skin adhesive glue | 0 | 54 | 1 | 54 | 1 | 54 |
| EG002 | Polyester Mesh + Dermabond | The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study Polyester mesh + Dermabond: conventional sutures and skin adhesive glue | 0 | 53 | 1 | 53 | 1 | 53 |
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