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This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. In other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The investigators wish to compare the effects of two versus five millimeter spacing between sutures.
Sutures are the standard of care in repairing cutaneous wounds. The majority of surgical reconstructions following a Mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer. The deep layer dissolves naturally whereas the top layer may necessitate removal if non-absorbable sutures are used. This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. In other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The investigators wish to compare the effects of two versus five millimeter spacing between sutures. It is possible that fewer, more widely spaced sutures may leave more open space in the wound, leaving more tension to pull on those few sutures, possibly encouraging the wound to dehisce and make it harder to approximate the wound edges yielding a less cosmetically appealing scar compared to placing many closely approximated sutures which would decrease the tension and likely better approximate the wound edges yielding a more cosmetically appealing scar. On the other hand, the investigators may find that suture spacing has no effect on wound cosmesis and that placing fewer, more widely spaced sutures is much more time efficient. The investigators may also find that the effect of suture spacing on wound cosmesis is dependent on wound tension. For example, perhaps the suture pacing would have no effect on the cosmesis of a wound under no tension, however, for a wound under high tension, it is possible that many closely approximated sutures would yield better cosmetic results for the reasons listed above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast absorbing gut suture placed 2 mm apart | Experimental | Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern |
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| Fast absorbing gut suture placed 5 mm apart | Experimental | Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast absorbing gut suture | Device | Fast absorbing surgical gut suture is a strand of collagenous material |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Posas Score | Scale name: Patient Observer Scar Assessment Score. Scale measures six parameters of scars, each using a 10-point scoring system (the six categories are summed to achieve the POSAS score - totals range from 6 to 60), with 1 representing normal skin & 10 representing the most severe scar imaginable. | 3 months following procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Width of Scar | A secondary endpoint will include the width of the scar 1 cm from midline on each side. This measurement will be reported in mm | 3 months following procedure |
| Erythema | If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis, Department of Dermatology | Sacramento | California | 95816 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30649154 | Derived | Sklar LR, Pourang A, Armstrong AW, Dhaliwal SK, Sivamani RK, Eisen DB. Comparison of Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis of the Face and Neck: A Randomized Clinical Trial. JAMA Dermatol. 2019 Mar 1;155(3):321-326. doi: 10.1001/jamadermatol.2018.5057. |
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This randomized clinical trial was conducted at the University of California, Davis dermatology clinic from November 28, 2017, to June 15, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | A split wound model was used, where half of the wound was repaired with sutures placed 2 millimeters apart and the other half is repaired with sutures placed 5 millimeters apart. A predetermined, concealed randomization number was obtained from the RedCap randomization module, which specified how Side A was treated. Side B was treated the opposite way as A. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart | Wound closed with sutures spaced 2 and 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material |
| 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 | Patient Posas Score | Scale name: Patient Observer Scar Assessment Score. Scale measures six parameters of scars, each using a 10-point scoring system (the six categories are summed to achieve the POSAS score - totals range from 6 to 60), with 1 representing normal skin & 10 representing the most severe scar imaginable. | Posted | Mean | Standard Deviation | score on a scale | 3 months following procedure |
|
At 3-Month Follow-up
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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 | Fast Absorbing Gut Suture Placed 2 mm Apart | Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Eisen, M.D. | University of California, Davis, Department of Dermatology | 916-734-6479 | dbeisen@ucdavis.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 | Oct 30, 2017 | Oct 22, 2019 | Prot_SAP_000.pdf |
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At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
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| 3 months following procedure |
| 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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Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, running cuticular suture pattern.
Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.
|
|
| Secondary | Width of Scar | A secondary endpoint will include the width of the scar 1 cm from midline on each side. This measurement will be reported in mm | Posted | Mean | Standard Deviation | mm | 3 months following procedure |
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| Secondary | Erythema | If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported | Posted | Count of Participants | Participants | 3 months following procedure |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Fast Absorbing Gut Suture Placed 5 mm Apart | Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material | 0 | 50 | 0 | 50 | 0 | 50 |
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