Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Investigator's Assessment of Wound Closure Device (Questionnaire) |
The investigator will complete a questionnaire about the wound. The questionnaire will capture information about the wound including the cause of laceration, approximate length of the wound, and whether subcutaneous sutures were used prior to application of micro Mend or sutures. The questionnaire will also indicate whether local anesthesia was used. |
During wound-closure performance |
|
Primary |
Investigator's Assessment of Wound Closure Device (Survey) |
The investigator will rate the performance of the wound closure device using a survey to rate the ease of use, speed of use, wound appearance, and provide an overall rating for the experience of using the wound closure device. Each parameter will be determined to be Excellent, Good, Fair or Poor, which correspond to numerical ratings of 4, 3, 2, and 1, respectively. |
During wound-closure procedure |
|
Secondary |
Total Procedure Time |
The investigator or designee will record the total procedure time from the initiation of anesthesia (if used) to completion of closure of the laceration. |
During wound-closure procedure |
|
Secondary |
Wound Closure Time |
The investigator or designee will record the time of the wound closure portion of the procedure measured from initiation of first suture or microMend application to completion of the closure. |
During wound-closure procedure |
|
Secondary |
Subject assessment of level of pain during wound closure procedure |
The Visual Analogue Pain Scale (VAS) is used to measure endpoints on a scale of 0 to 10, with 0 and 10 representing both extremes. To perform the evaluation, the Subject is asked to place a mark on a straight line that has a 0 on the left end and a 10 on the right end of the line. A score of 0 will indicate no pain, while a score of 10 indicates the worst pain imaginable. |
The VAS Score for level of pain during the wound closure procedure will be collected on the day of the wound closure procedure (Study Day 0). |
|
Secondary |
Comparison of Provider's rating of wound closure results with microMend to suture |
The provider will compare wound closure results between microMend and sutures at the first return clinic visit. |
1 month after wound-closure procedure |
|
Secondary |
Subject assessment of level of stress during wound closure procedure |
The VAS Score is used to measure endpoints on a scale of 0 to 10, with 0 and 10 representing both extremes. To perform the evaluation, the Subject is asked to place a mark on a straight line that has a 0 on the left end and a 10 on the right end of the line. A score of 0 will indicate no stress, while a score of 10 indicates the worst stress imaginable. |
The VAS Score for level of stress during the wound closure procedure will be collected on the day of the wound closure procedure (Study Day 0). |
|
Secondary |
The VAS Score for level of stress during the wound closure procedure will be collected on the day of the wound closure procedure (Study Day 0). |
The VAS Score is used to measure endpoints on a scale of 0 to 10, with 0 and 10 representing both extremes. To perform the evaluation, the Subject is asked to place a mark on a straight line that has a 0 on the left end and a 10 on the right end of the line. A score of 0 will indicate no pain, while a score of 10 indicates the worst pain imaginable. |
The VAS Score for level of pain during removal of the wound closure device will be collected at the First Return Clinic Visit, Day 5 (5-7) for facial lacerations or Day 8 (7-10) for lacerations elsewhere on the body. |
|
Secondary |
Subject assessment of level of stress during removal of wound closure device |
The VAS Score is used to measure endpoints on a scale of 0 to 10, with 0 and 10 representing both extremes. To perform the evaluation, the Subject is asked to place a mark on a straight line that has a 0 on the left end and a 10 on the right end of the line. A score of 0 will indicate no stress, while a score of 10 indicates the worst stress imaginable. |
The VAS Score for level of stress during removal of the wound closure device will be collected on the day of the wound closure procedure (Study Day 0). |
|
Secondary |
Visual Assessment of wound in individual Subjects taken both before and after application of wound closure device |
At least two (2) photographs of each wound will be taken before and after application of wound closure device. An Independent Plastic Surgeon will rate wound appearance and cosmetic results on a 0-10 scale, where 10 indicates the best possible appearance and results, while a score of 0 indicates the worst possible results.product. |
Photographs will be taken both before and after application of the wound closure device on the day of the wound closure procedure (Day 0). Photographs will be reviewed by an Independent Plastic Surgeon to assess wound appearance and cosmetic results. |
|
Secondary |
Visual Assessment of wound in individual Subjects taken both before and after removal of wound closure device |
At least two (2) photographs of each wound will be taken before and after application of wound closure device. An Independent Plastic Surgeon will rate wound appearance and cosmetic results on a 0-10 scale, where 10 indicates the best possible appearance and results, while a score of 0 indicates the worst possible results. |
Photographs will be taken both before and after removal of the wound closure device on the day of the wound closure procedure (Day 5-7 for facial lacerations, Day 7-10 for lacerations elsewhere on the body). Photographs will be reviewed by an Independent |
|
Secondary |
Visual Assessment of wound after 1 Month |
At least two (2) photographs of each wound will be taken 1 month after initial application of the wound closure device. An Independent Plastic Surgeon will rate wound appearance and cosmetic results on a 0-10 scale, where 10 indicates the best possible appearance and results, while a score of 0 indicates the worst possible results. |
A minimum of two photographs of each wound will be taken 1 month after initial application of the wound closure device. Photographs will be reviewed by an Independent Plastic Surgeon to assess wound appearance and cosmetic results. |
|
Secondary |
Visual Assessment of wound after 3 Months |
At least two (2) photographs of each wound will be taken 3 months after initial application of the wound closure device. An Independent Plastic Surgeon will rate wound appearance and cosmetic results on a 0-10 scale, where 10 indicates the best possible appearance and results, while a score of 0 indicates the worst possible results. |
A minimum of two photographs of each wound will be taken 3 months after initial application of the wound closure device. Photographs will be reviewed by an Independent Plastic Surgeon to assess wound appearance and cosmetic results. |
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