Surgical Wound
Conditions
Keywords
Subcuticular suture, Subcuticular staple, Skin closure, Incision closure, Wound
Brief summary
Currently, the way doctors close the skin during cesarean section is different between surgeons and there is little evidence to support the use of one kind of closure over the other. At the Mayo Clinic Family Birth Center, skin is currently closed using an absorbable suture (or stitch), placed within the top layer of skin. At other institutions, a metal staple is often used to close the skin. There is a new technique that uses special absorbable staples just beneath the skin. This technology may be equal to, or possibly better than, current skin closure techniques. However, there is currently little data to show how it compares. The purpose of this study is to compare the absorbable staple to the currently used absorbable suture. The data from this study will then be used to help determine the best technique for skin closure.
Detailed description
Cesarean section is one of the most frequently performed surgical procedures worldwide. In the United States, the proportion of deliveries by cesarean has increased from approximately 21% in 1996 to 32.8% in 2010. Ultimately, the rising incidence of cesarean delivery results in increased surgical morbidity; including pain, blood loss, and surgical site infections, which leads to an increase in overall hospitalization days and healthcare costs. This volume of surgical procedures also carries the risk of blood and body fluid exposures to surgical staff. Suture needles contribute to 43.4% of all sharps injuries in surgical settings and 51.5% of sharp injuries to surgeons alone. Additionally, it was discovered that 20% of blood borne pathogen exposures on the Mayo Clinic Rochester campus in 2011 occurred in the Department of Obstetrics and Gynecology. Therefore, any quality improvement measure regarding cesarean sections has the potential to significantly impact overall surgical morbidity, bloodborne pathogen exposure, and healthcare costs at our institution. Reviews of current literature show a lack of evidence for many of the surgical steps during cesarean procedures. Thus, there is an urgent need to define evidence-based surgical techniques for each step, from incision to closure. The optimal skin closure technique is simple, quick, cost-effective, and provides adequate tissue approximation with a good cosmetic outcome while minimizing the risk of infection, dehiscence, and pain. Ideally, needlestick injuries would also be eliminated. It is currently unknown which skin closure method is superior with regard to these outcomes. The INSORB 20 (Incisive Surgical) is a new, single-use device for skin closure that aims to combine the speed of a staple with the cosmetic outcome of a subcuticular suture, while eliminating the need for staple removal. Additionally, it should reduce the incidence of needlestick injury. INSORB also claims to result in a low maintenance wound with less surgical site infection, lower inflammation, and increased patient comfort and satisfaction. However, data is limited comparing INSORB to the current standards of care (either staples or suture). The purpose of this study is to determine if the new absorbable subcuticular staples (INSORB) improves outcomes compared to the current standard absorbable subcuticular suture for skin closure in cesarean sections.
Interventions
DEVICESubcuticular suture
subcuticular Monocryl suture closure
DEVICESubcuticular staple
subcuticular staple wound closure with INSORB 20 device
Sponsors
Margaret L. Dow, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Gestational age ≥ 24 weeks * Scheduled cesarean section for any indication * Pfannenstiel incision * Singleton gestation
Exclusion criteria
* Failure to consent * Gestational age \< 24 weeks * Vaginal delivery * Intrauterine fetal death * Multifetal gestation * Suspected infection, i.e. chorioamnionitis * BMI \> 50
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Surgical Time, All Resident Levels | Measured at the time of the procedure (day 1), approximately 1 hour after incision start | Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate). |
| Skin Closure Time, All Resident Levels | Measured at the time of the procedure (day 1), approximately 1 hour after incision start | Measured for all resident education levels (1 to 4 years postgraduate). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | From day of procedure until end of hospital stay (typical dismissal on day 4) | Post-operative pain was assessed by pain medication use through chart review. |
| Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic | From day of procedure until end of hospital stay (typical dismissal on day 4) | Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen . |
| Total Number of Participants With Postoperative Complications | From the day of the procedure (Day 1) for 6 weeks | Postoperative complications were assessed by chart review. |
| Surgeon Satisfaction (Per Procedure) | Immediately after the procedure (day 1) | Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision? How willing are you to recommend this skin closure (whether it was staples or suture) to a patient? How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section? There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with not at all,' not very, and no opinion being a negative response, and somewhat and extremely being a positive response. Categories reported were negative, (including no opinion), and positive. |
| Cosmetic Outcome | Measured at 6 week postoperative appointment | The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar. |
| Patient Satisfaction | At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment | Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely). |
| Participants With Postoperative Complications, by Type | From the day of the procedure (Day 1) for 6 weeks | Postoperative complications were assessed by chart review. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the Mayo Clinic Family Birth Center (labor and delivery) in Rochester, Minnesota. Subjects were recruited from December 2012 until the end of April 2014.
Pre-assignment details
220 subjects were randomized to suture or absorbable subcuticular staples and 206 were included in the final analysis with 103 in each group. One subject crossed over from absorbable subcuticular staples to suture intraoperatively, because the attending surgeon was not comfortable with the staple closure device.
Participants by arm
| Arm | Count |
|---|---|
| Subcuticular Suture Subcuticular suture has been used for many years to close skin incisions. | 103 |
| Subcuticular Staple Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique. | 103 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Intention-to-Treat Analysis | Body Mass Index>50 | 0 | 1 |
| Intention-to-Treat Analysis | Missing consent form | 5 | 3 |
| Intention-to-Treat Analysis | Multifetal gestation | 2 | 3 |
| Postpartum Follow-up | Lost to Follow-up | 22 | 15 |
Baseline characteristics
| Characteristic | Subcuticular Staple | Total | Subcuticular Suture |
|---|---|---|---|
| Age, Continuous | 31 years | 30.5 years | 30 years |
| Region of Enrollment United States | 103 participants | 206 participants | 103 participants |
| Resident year of postgraduate education | 2 years | 2 years | 2 years |
| Sex: Female, Male Female | 103 Participants | 206 Participants | 103 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 93 | 6 / 96 |
| serious Total, serious adverse events | 0 / 93 | 0 / 96 |
Outcome results
Primary
Skin Closure Time, All Resident Levels
Measured for all resident education levels (1 to 4 years postgraduate).
Time frame: Measured at the time of the procedure (day 1), approximately 1 hour after incision start
Population: Intention-to-Treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subcuticular Suture | Skin Closure Time, All Resident Levels | 8.5 minutes |
| Subcuticular Staple | Skin Closure Time, All Resident Levels | 2.6 minutes |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
Total Surgical Time, All Resident Levels
Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate).
Time frame: Measured at the time of the procedure (day 1), approximately 1 hour after incision start
Population: Intention-to-Treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subcuticular Suture | Total Surgical Time, All Resident Levels | 58.0 minutes |
| Subcuticular Staple | Total Surgical Time, All Resident Levels | 54.0 minutes |
p-value: 0.053Wilcoxon (Mann-Whitney)
Secondary
Cosmetic Outcome
The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar.
Time frame: Measured at 6 week postoperative appointment
Population: Not all patients or observers completed the scales. For the six items on the patient scale, N=44:52, but the overall opinion responding was N=43:51. For the observer scale the number responding was N=43:52 for vascularity, thickness, pliability, and surface area. N=42:52 for pigmentation and relief; N=42:50 for overall opinion.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Subcuticular Suture | Cosmetic Outcome | Patient: scar overall opinion | 4.4 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Patient: scar stiffness is different | 5.0 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Observer: vascularity | 2.9 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Patient: scar painful | 2.2 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Patient: scar more irregular | 4.4 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Patient: scar itching | 2.2 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Observer: thickness | 2.7 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Observer: pigmentation | 3.2 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Patient: scar thickness is different | 4.6 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Observer: pliability | 2.7 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Observer: relief | 2.5 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Observer: surface area | 2.5 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Observer: overall opinion | 2.8 units on a scale |
| Subcuticular Suture | Cosmetic Outcome | Patient: scar color is different | 5.3 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Observer: relief | 2.6 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Patient: scar stiffness is different | 3.7 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Patient: scar thickness is different | 4.0 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Patient: scar more irregular | 3.6 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Patient: scar overall opinion | 3.8 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Observer: vascularity | 2.8 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Observer: thickness | 2.6 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Patient: scar color is different | 3.9 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Observer: surface area | 2.5 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Observer: overall opinion | 2.6 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Patient: scar painful | 1.8 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Patient: scar itching | 1.9 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Observer: pigmentation | 2.5 units on a scale |
| Subcuticular Staple | Cosmetic Outcome | Observer: pliability | 2.8 units on a scale |
Comparison: Comparison between arms for patient: scar more irregular.p-value: 0.13Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for patient: overall opinion.p-value: 0.11Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for patient: scar painful.p-value: 0.35Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for patient: scar itching.p-value: 0.48Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for patient: scar color is different.p-value: 0.034Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for patient: scar stiffness is different.p-value: 0.041Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for patient: scar thickness is different.p-value: 0.23Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for observer: vascularity.p-value: 0.68Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for observer: pigmentation.p-value: 0.18Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for observer: thicknessp-value: 0.75Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for observer: relief.p-value: 0.36Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for observer: pliability.p-value: 0.78Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for observer: surface area.p-value: 0.76Wilcoxon (Mann-Whitney)
Comparison: Comparison between arms for observer: overall opinion.p-value: 0.97Wilcoxon (Mann-Whitney)
Secondary
Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic
Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen .
Time frame: From day of procedure until end of hospital stay (typical dismissal on day 4)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcuticular Suture | Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic | Patient-controlled analgesia | 5 participants |
| Subcuticular Suture | Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic | Alternative oral analgesic | 6 participants |
| Subcuticular Suture | Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic | Single dose IV/IM analgesic | 16 participants |
| Subcuticular Staple | Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic | Patient-controlled analgesia | 6 participants |
| Subcuticular Staple | Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic | Alternative oral analgesic | 9 participants |
| Subcuticular Staple | Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic | Single dose IV/IM analgesic | 22 participants |
Secondary
Participants With Postoperative Complications, by Type
Postoperative complications were assessed by chart review.
Time frame: From the day of the procedure (Day 1) for 6 weeks
Population: Participants could have experienced more than one type of postoperative complication. Note: wound dehiscence is a surgical complication in which a wound ruptures along surgical suture. A seroma is a pocket of clear serous fluid. A hematoma is a localized swelling that is filled with blood caused by a break in the wall of a blood vessel.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcuticular Suture | Participants With Postoperative Complications, by Type | Superficial Wound Separation | 4 participants |
| Subcuticular Suture | Participants With Postoperative Complications, by Type | Seroma | 1 participants |
| Subcuticular Suture | Participants With Postoperative Complications, by Type | Surgical Site Infection | 4 participants |
| Subcuticular Suture | Participants With Postoperative Complications, by Type | Hematoma | 0 participants |
| Subcuticular Suture | Participants With Postoperative Complications, by Type | Complete Wound Dehiscence | 0 participants |
| Subcuticular Suture | Participants With Postoperative Complications, by Type | No Postoperative Complications | 86 participants |
| Subcuticular Suture | Participants With Postoperative Complications, by Type | Staple Expulsion or Suture Trimming | 0 participants |
| Subcuticular Staple | Participants With Postoperative Complications, by Type | No Postoperative Complications | 90 participants |
| Subcuticular Staple | Participants With Postoperative Complications, by Type | Staple Expulsion or Suture Trimming | 3 participants |
| Subcuticular Staple | Participants With Postoperative Complications, by Type | Surgical Site Infection | 1 participants |
| Subcuticular Staple | Participants With Postoperative Complications, by Type | Superficial Wound Separation | 1 participants |
| Subcuticular Staple | Participants With Postoperative Complications, by Type | Complete Wound Dehiscence | 0 participants |
| Subcuticular Staple | Participants With Postoperative Complications, by Type | Seroma | 0 participants |
| Subcuticular Staple | Participants With Postoperative Complications, by Type | Hematoma | 2 participants |
Comparison: Comparison for staple expulsion or suture trimmingp-value: 0.25Fisher Exact
Comparison: Comparison for Surgical Site Infectionp-value: 0.06Fisher Exact
Comparison: Comparison for Superficial Wound Separationp-value: 0.21Fisher Exact
Comparison: Comparison for Seromap-value: 0.49Fisher Exact
Comparison: Comparison for Hematomap-value: 0.5Fisher Exact
Secondary
Patient Satisfaction
Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely).
Time frame: At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment
Population: The reduction in the number of participants analyzed is due to not all participants completing the questionnaire, and all the questions. For appearance of incision, N=58:69. For willingness to use treatment again, N=59:68.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcuticular Suture | Patient Satisfaction | Appearance of incision: negative | 3 participants |
| Subcuticular Suture | Patient Satisfaction | Appearance of incision: positive | 55 participants |
| Subcuticular Suture | Patient Satisfaction | Would recommend: negative | 11 participants |
| Subcuticular Suture | Patient Satisfaction | Would recommend: positive | 48 participants |
| Subcuticular Suture | Patient Satisfaction | Willingness (again): negative | 8 participants |
| Subcuticular Suture | Patient Satisfaction | Willingness (again): positive | 51 participants |
| Subcuticular Suture | Patient Satisfaction | Overall satisfaction: negative | 4 participants |
| Subcuticular Suture | Patient Satisfaction | Overall satisfaction: positive | 55 participants |
| Subcuticular Staple | Patient Satisfaction | Overall satisfaction: positive | 67 participants |
| Subcuticular Staple | Patient Satisfaction | Appearance of incision: negative | 6 participants |
| Subcuticular Staple | Patient Satisfaction | Willingness (again): negative | 7 participants |
| Subcuticular Staple | Patient Satisfaction | Appearance of incision: positive | 63 participants |
| Subcuticular Staple | Patient Satisfaction | Overall satisfaction: negative | 2 participants |
| Subcuticular Staple | Patient Satisfaction | Would recommend: negative | 6 participants |
| Subcuticular Staple | Patient Satisfaction | Willingness (again): positive | 61 participants |
| Subcuticular Staple | Patient Satisfaction | Would recommend: positive | 63 participants |
Comparison: Comparison for negative responses to Appearance of incision question.p-value: 0.51Fisher Exact
Comparison: Comparison for negative responses to Would recommend treatment to friends question.p-value: 0.098Chi-squared
Comparison: Comparison of negative responses to Willingness to use treatment again question.p-value: 0.57Chi-squared
Comparison: Comparison of negative responses to Overall satisfaction question.p-value: 0.41Fisher Exact
Secondary
Postoperative Pain
Post-operative pain was assessed by pain medication use through chart review.
Time frame: From day of procedure until end of hospital stay (typical dismissal on day 4)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subcuticular Suture | Postoperative Pain | Oxycodone | 60 mg |
| Subcuticular Suture | Postoperative Pain | Tylenol | 12000 mg |
| Subcuticular Suture | Postoperative Pain | Ibuprofen | 5400 mg |
| Subcuticular Suture | Postoperative Pain | Toradol | 45 mg |
| Subcuticular Staple | Postoperative Pain | Toradol | 45 mg |
| Subcuticular Staple | Postoperative Pain | Oxycodone | 60 mg |
| Subcuticular Staple | Postoperative Pain | Ibuprofen | 4800 mg |
| Subcuticular Staple | Postoperative Pain | Tylenol | 12000 mg |
Comparison: Comparison between the arms for Tylenol use.p-value: 0.48Wilcoxon (Mann-Whitney)
Comparison: Comparison between the arms for Ibuprofen use.p-value: 0.3Wilcoxon (Mann-Whitney)
Comparison: Comparison between the arms for Toradol use.p-value: 0.85Wilcoxon (Mann-Whitney)
Comparison: Comparison between the arms for Oxycodone use.p-value: 0.78Wilcoxon (Mann-Whitney)
Secondary
Surgeon Satisfaction (Per Procedure)
Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision? How willing are you to recommend this skin closure (whether it was staples or suture) to a patient? How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section? There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with not at all,' not very, and no opinion being a negative response, and somewhat and extremely being a positive response. Categories reported were negative, (including no opinion), and positive.
Time frame: Immediately after the procedure (day 1)
Population: A satisfaction survey wasn't completed for all of the procedures (103 per arm), so the reporting population is 91 for the suture arm, and 96 for the staple arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcuticular Suture | Surgeon Satisfaction (Per Procedure) | Recommend: positive | 77 Surgeons reporting per category |
| Subcuticular Suture | Surgeon Satisfaction (Per Procedure) | Appearance of incision: positive | 85 Surgeons reporting per category |
| Subcuticular Suture | Surgeon Satisfaction (Per Procedure) | Willingness to use again: negative | 16 Surgeons reporting per category |
| Subcuticular Suture | Surgeon Satisfaction (Per Procedure) | Recommend: negative | 14 Surgeons reporting per category |
| Subcuticular Suture | Surgeon Satisfaction (Per Procedure) | Willingness to use again: positive | 75 Surgeons reporting per category |
| Subcuticular Suture | Surgeon Satisfaction (Per Procedure) | Appearance of incision: negativ | 6 Surgeons reporting per category |
| Subcuticular Staple | Surgeon Satisfaction (Per Procedure) | Willingness to use again: positive | 94 Surgeons reporting per category |
| Subcuticular Staple | Surgeon Satisfaction (Per Procedure) | Appearance of incision: negativ | 7 Surgeons reporting per category |
| Subcuticular Staple | Surgeon Satisfaction (Per Procedure) | Recommend: negative | 3 Surgeons reporting per category |
| Subcuticular Staple | Surgeon Satisfaction (Per Procedure) | Recommend: positive | 93 Surgeons reporting per category |
| Subcuticular Staple | Surgeon Satisfaction (Per Procedure) | Willingness to use again: negative | 2 Surgeons reporting per category |
| Subcuticular Staple | Surgeon Satisfaction (Per Procedure) | Appearance of incision: positive | 89 Surgeons reporting per category |
Comparison: Comparison between arms for appearance of incision.p-value: 0.85Chi-squared
Comparison: Comparison between arms for recommend treatment.p-value: 0.004Chi-squared
Comparison: Comparison between arms for willingness to use treatment again.p-value: <0.001Chi-squared
Secondary
Total Number of Participants With Postoperative Complications
Postoperative complications were assessed by chart review.
Time frame: From the day of the procedure (Day 1) for 6 weeks
Population: The number of participants analyzed was reduced because some patients did not return for postpartum followup visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subcuticular Suture | Total Number of Participants With Postoperative Complications | 7 participants |
| Subcuticular Staple | Total Number of Participants With Postoperative Complications | 6 participants |
p-value: 0.73Chi-squared