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The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure.
The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure. Our aims are to compare outcomes using a split wound model, where half the wound is sutured with one technique and the other half is sutured with the other. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wounds with a single layer closure will result in cosmetically superior wound outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermal Suturing Only Wound Closure | Active Comparator | The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion. |
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| Layered Cutaneous Wound Closure | Active Comparator | The side assigned to layered closure is closed with 5-0 fast acting gut. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermal Suturing Only Wound Closure | Procedure | The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months | After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques. | 3 months |
| Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months | After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 12 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Scar Width | The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects. | 3 months and 12 months |
| Assessment of Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Eisen, M.D. | University of California, Davis | Principal Investigator |
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| Label | URL |
|---|---|
| University of California-Davis Department of Dermatology Clinical Research | View source |
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| Layered Cutaneous Wound Closure | Procedure | The side assigned to layered closure is closed with 5-0 fast acting gut. |
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Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures. |
| 3 months and 12 months |