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This study is trying to find out if there is one method of surgical incision closure is better than another. The three different wound closure methods in this study are currently used in standard of care. The three methods being compared are standard stitches and the wound closure devices, Clozex, and Zipline. All of these methods are approved by the FDA.
There are many surgical wound closure methods commonly used in practice today. These usually involve a combination of braided and monofilament sutures in the subcutaneous fascia and fat as well as the subcuticular layers of the skin. The methods chosen by surgeons vary widely even amongst partners at the same institution for many reasons, including training background and conflicting reports in the literature. In some cases, these closure techniques can be time consuming and associated with increased rates of poor cosmetic outcomes or complications. There have been new wound closure products to reach the market that have been designed (Zipline - Campbell, CA and Clozex - Wellesley, MA), claiming to increase the speed of closure and decrease the rate of complications. These products both utilize an adhesive backed film to adhere to the skin along with a proprietary method to enhance skin apposition to reduce tension during the healing process. There has been no randomized controlled trial to determine superiority of the above listed surgical closure methods compared to traditional methods.
Our study aims to compare a "traditional" wound closure using both braided and monofilament sutures to the newer wound closure systems. By determining which method provides superior results, we will improve patient outcomes and satisfaction. The study also aims to assess health care value by exploring the costs associated with each closure technique. In addition to material expenses associated with the traditional sutures, we seek to explore if there is a significant difference in the time required to perform each wound closure method. Every minute of anesthesia and operating room utilization is associated with costs borne by the patient and the health care system. By finding which closure method is the fastest and associated with the best outcome we can improve healthcare value.
These methods will be tested in a randomized controlled trial and will be analyzed with multivariate statistical analysis to examine statistical significance. Subjects will be randomized in a 1:1:1 fashion to sutures, Closex, or Zipline. Surgeons will complete a satisfaction questionnaire about the randomized method used for closure. Surgical subjects will complete a satisfaction questionnaire at two follow up visits that align with standard of care visits and will have the incision measured and examined. Our primary objective outcome measure will be an assessment of surgical scar dimensions. Our hypothesis is that the 3 study groups will have similar objective scar measurements but that the savings in time associated with the new wound closure methods will be significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture | Active Comparator | Standard suture wound closure |
|
| Adhesive wound closure device | Active Comparator | Clozex wound closure device |
|
| Adhesive wound closure device with zip ties | Active Comparator | Zipline wound closure device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture | Device | Standard suture wound closure device. |
| |
| Clozex |
| Measure | Description | Time Frame |
|---|---|---|
| Stony Brook Scar Evaluation Scale | Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing | 2-Weeks post-operative |
| Stony Brook Scar Evaluation Scale | Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing | 3-Months post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Close | The amount of time in seconds that it took to perform closure of the incision. | During the procedure, from beginning of wound closure to the completion of wound closure |
| Length of Incision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Miller, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36155955 | Derived | Burke JF, MacLean IS, Smith JM, Hart JM, Miller MD. A Prospective, Randomized, Controlled Comparison of Adhesive Wound Closure Devices in an Orthopaedic Patient. J Am Acad Orthop Surg Glob Res Rev. 2022 Sep 23;6(9):e22.00179. doi: 10.5435/JAAOSGlobal-D-22-00179. eCollection 2022 Sep 1. |
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Individual data will not be share. Group means will be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Suture | Standard suture wound closure Suture: Standard suture wound closure device. |
| FG001 | Adhesive Wound Closure Device | Clozex wound closure device Clozex: Interlaced adhesive wound closure device. |
| FG002 | Adhesive Wound Closure Device With Zip Ties | Zipline wound closure device Zipline: Adhesive wound closure device using zip-tie like strips. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This is the number of subjects included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Suture | Standard suture wound closure Suture: Standard suture wound closure device. |
| BG001 | Adhesive Wound Closure Device | Clozex wound closure device Clozex: Interlaced adhesive wound closure device. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Stony Brook Scar Evaluation Scale | Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing | Posted | Mean | Standard Deviation | score on a scale | 2-Weeks post-operative |
|
3 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 | Suture | Standard suture wound closure Suture: Standard suture wound closure device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Miller | University of Virginia | (434) 243-7778 | mdm3p@uvahealth.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 | Jul 29, 2022 | Jul 23, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 3, 2019 | Jan 21, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Device |
Interlaced adhesive wound closure device. |
|
| Zipline | Device | Adhesive wound closure device using zip-tie like strips. |
|
This is the measure in centimeters of the incision.
| During the procedure, obtained after incision was closed. |
| Patient Satisfaction | Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction. | 2 weeks post operative |
| Patient Satisfaction | Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction. | 3 months post operative |
| Surgeon Satisfaction | Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower satisfaction. | Once (at application) |
| BG002 | Adhesive Wound Closure Device With Zip Ties | Zipline wound closure device Zipline: Adhesive wound closure device using zip-tie like strips. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| Region of Enrollment | Count of Participants | Participants |
|
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|
| Primary | Stony Brook Scar Evaluation Scale | Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing | All subjects who completed 3-Month follow-up and were randomized to their respective wound closure device. | Posted | Mean | Standard Deviation | score on a scale | 3-Months post operative |
|
|
|
| Secondary | Time to Close | The amount of time in seconds that it took to perform closure of the incision. | Posted | Mean | Standard Deviation | seconds | During the procedure, from beginning of wound closure to the completion of wound closure |
|
|
|
| Secondary | Length of Incision | This is the measure in centimeters of the incision. | Posted | Mean | Standard Deviation | centimeters | During the procedure, obtained after incision was closed. |
|
|
|
| Secondary | Patient Satisfaction | Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks post operative |
|
|
|
| Secondary | Patient Satisfaction | Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction. | Posted | Mean | Standard Deviation | units on a scale | 3 months post operative |
|
|
|
| Secondary | Surgeon Satisfaction | Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower satisfaction. | Posted | Mean | Standard Deviation | units on a scale | Once (at application) |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Adhesive Wound Closure Device | Clozex wound closure device Clozex: Interlaced adhesive wound closure device. | 0 | 19 | 0 | 19 | 2 | 19 |
| EG002 | Adhesive Wound Closure Device With Zip Ties | Zipline wound closure device Zipline: Adhesive wound closure device using zip-tie like strips. | 0 | 18 | 0 | 18 | 2 | 18 |
| blisters | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|