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This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter 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 layer and a top layer. The deep layer dissolves naturally whereas the top layer must be removed.
This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter 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, we 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 investigator 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 |
|---|---|---|---|
| Vicryl absorbable suture placed 2 cm apart | Experimental | Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern |
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| Vicryl absorbable suture placed 1 cm apart | Experimental | Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicryl absorbable suture | Device | Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale - Reviewer 1 | The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes. | 3 months following procedure |
| Patient and Observer Scar Assessment Scale - Reviewer 2 | The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes. | 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 | 3 months following procedure |
| Complications | Any complications including suture reaction, dehiscence, infection, necrosis, bleeding, and hematoma |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis, Department of Dermatology | Sacramento | California | 95816 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35474448 | Derived | Eshagh K, Sklar LR, Pourang A, Armstrong AW, Dhaliwal H, Eisen DB. Interrupted subcuticular suture spacing during linear wound closures and the effect on wound cosmesis: a randomized evaluator-blinded split-wound comparative effectiveness trial. Br J Dermatol. 2022 Sep;187(3):318-323. doi: 10.1111/bjd.21625. Epub 2022 Jun 13. |
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The surgeons recruited patients for the study from their cutaneous surgical practices.
| ID | Title | Description |
|---|---|---|
| FG000 | Vicryl Absorbable Suture Placed 2 cm Apart | Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer |
| FG001 | Vicryl Absorbable Suture Placed 1 cm Apart | Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Out of 50 patients, each wound was split into half, with each side receiving one of the two interventions, for a total of 100 wound halves analyzed. For each patient, one side of wound received buried vertical mattress subcuticular sutures spaced 1cm apart versus the other side receiving sutures spaced 2cm apart.
| ID | Title | Description |
|---|---|---|
| BG000 | Vicryl Absorbable Suture Placed 2 cm Apart | Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer |
| BG001 | Vicryl Absorbable Suture Placed 1 cm Apart |
| 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 | Patient and Observer Scar Assessment Scale - Reviewer 1 | The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes. | Out of 46 patients, each patient's wound was then divided into 2 sides: A and B. An intervention was randomly assigned to each side of the wound, for a total of 92 wound halves. | Posted | Mean | Full Range | score on a scale | 3 months following procedure | wound halves | wound halves |
|
Any data about adverse events was collected over the 3 months following the patient's procedure.
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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 | Vicryl Absorbable Suture Placed 2 cm Apart | Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer |
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The primary limitation of our study includes its single center nature. A multicenter study would allow for narrower confidence intervals and a more diverse patient population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel B. Eisen | Department of Dermatology, UC Davis | 916-551-2611 | 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 | Dec 14, 2017 | Jun 15, 2023 | 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 |
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer |
| BG002 | Total | Total of all reporting groups |
| Wound halves |
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| years |
| Wound halves |
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| Sex: Female, Male | Count of Units | Wound halves | Wound halves |
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| Race (NIH/OMB) | Count of Units | Wound halves | Wound halves |
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| Closure Length | Mean | Standard Deviation | centimeters | Wound halves |
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| Location of Surgical Procedure | Count of Units | Wound halves | Wound halves |
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| Surgeon Experience | Count of Units | Wound halves | Wound halves |
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| Indication for Surgery | Count of Units | Wound halves | Wound halves |
|
| OG001 | Vicryl Absorbable Suture Placed 1 cm Apart | Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer |
|
|
|
| Primary | Patient and Observer Scar Assessment Scale - Reviewer 2 | The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes. | Posted | Mean | Full Range | score on a scale | 3 months following procedure | Wound halves | Wound halves |
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| Secondary | Width of Scar | A secondary endpoint will include the width of the scar 1 cm from midline on each side | Posted | Mean | Full Range | cm | 3 months following procedure | wound halves | wound halves |
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| Secondary | Complications | Any complications including suture reaction, dehiscence, infection, necrosis, bleeding, and hematoma | Out of 46 patients, each patient's wound was then divided into 2 sides: A and B. An intervention was randomly assigned to each side of the wound, for a total of 92 wound halves. | Posted | Number | Wound halves | 3 months following procedure | Wound halves | Wound halves |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Vicryl Absorbable Suture Placed 1 cm Apart | Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer | 0 | 50 | 0 | 50 | 0 | 50 |
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| Itching |
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| Color |
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| Stiffness |
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| Thickness |
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| Irregularity |
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| Overall opinion |
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