Trial Outcomes & Findings for A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure (NCT NCT01753518)
NCT ID: NCT01753518
Last Updated: 2015-04-30
Results Overview
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).
COMPLETED
NA
220 participants
Measured at the time of the procedure (day 1), approximately 1 hour after incision start
2015-04-30
Participant Flow
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.
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.
Participant milestones
| Measure |
Subcuticular Suture
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Intention-to-Treat Analysis
STARTED
|
110
|
110
|
|
Intention-to-Treat Analysis
COMPLETED
|
103
|
103
|
|
Intention-to-Treat Analysis
NOT COMPLETED
|
7
|
7
|
|
Postpartum Follow-up
STARTED
|
103
|
103
|
|
Postpartum Follow-up
COMPLETED
|
81
|
88
|
|
Postpartum Follow-up
NOT COMPLETED
|
22
|
15
|
Reasons for withdrawal
| Measure |
Subcuticular Suture
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Intention-to-Treat Analysis
Missing consent form
|
5
|
3
|
|
Intention-to-Treat Analysis
Multifetal gestation
|
2
|
3
|
|
Intention-to-Treat Analysis
Body Mass Index>50
|
0
|
1
|
|
Postpartum Follow-up
Lost to Follow-up
|
22
|
15
|
Baseline Characteristics
A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure
Baseline characteristics by cohort
| Measure |
Subcuticular Suture
n=103 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=103 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
n=93 Participants
|
31 years
n=4 Participants
|
30.5 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
206 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=93 Participants
|
103 participants
n=4 Participants
|
206 participants
n=27 Participants
|
|
Resident year of postgraduate education
|
2 years
n=93 Participants
|
2 years
n=4 Participants
|
2 years
n=27 Participants
|
PRIMARY outcome
Timeframe: Measured at the time of the procedure (day 1), approximately 1 hour after incision startPopulation: Intention-to-Treat
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).
Outcome measures
| Measure |
Subcuticular Suture
n=103 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=103 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Total Surgical Time, All Resident Levels
|
58.0 minutes
Interval 50.4 to 68.2
|
54.0 minutes
Interval 44.9 to 63.6
|
PRIMARY outcome
Timeframe: Measured at the time of the procedure (day 1), approximately 1 hour after incision startPopulation: Intention-to-Treat
Measured for all resident education levels (1 to 4 years postgraduate).
Outcome measures
| Measure |
Subcuticular Suture
n=103 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=103 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Skin Closure Time, All Resident Levels
|
8.5 minutes
Interval 6.2 to 10.5
|
2.6 minutes
Interval 1.8 to 4.0
|
SECONDARY outcome
Timeframe: From the day of the procedure (Day 1) for 6 weeksPopulation: The number of participants analyzed was reduced because some patients did not return for postpartum followup visits.
Postoperative complications were assessed by chart review.
Outcome measures
| Measure |
Subcuticular Suture
n=93 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=96 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Total Number of Participants With Postoperative Complications
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From the day of the procedure (Day 1) for 6 weeksPopulation: 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.
Postoperative complications were assessed by chart review.
Outcome measures
| Measure |
Subcuticular Suture
n=93 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=96 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Participants With Postoperative Complications, by Type
Staple Expulsion or Suture Trimming
|
0 participants
|
3 participants
|
|
Participants With Postoperative Complications, by Type
Surgical Site Infection
|
4 participants
|
1 participants
|
|
Participants With Postoperative Complications, by Type
Superficial Wound Separation
|
4 participants
|
1 participants
|
|
Participants With Postoperative Complications, by Type
Complete Wound Dehiscence
|
0 participants
|
0 participants
|
|
Participants With Postoperative Complications, by Type
Seroma
|
1 participants
|
0 participants
|
|
Participants With Postoperative Complications, by Type
Hematoma
|
0 participants
|
2 participants
|
|
Participants With Postoperative Complications, by Type
No Postoperative Complications
|
86 participants
|
90 participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Subcuticular Suture
n=103 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=103 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Postoperative Pain
Tylenol
|
12000 mg
Interval 11000.0 to 13000.0
|
12000 mg
Interval 9000.0 to 13000.0
|
|
Postoperative Pain
Ibuprofen
|
5400 mg
Interval 3600.0 to 6000.0
|
4800 mg
Interval 3600.0 to 6000.0
|
|
Postoperative Pain
Toradol
|
45 mg
Interval 45.0 to 45.0
|
45 mg
Interval 45.0 to 45.0
|
|
Postoperative Pain
Oxycodone
|
60 mg
Interval 30.0 to 100.0
|
60 mg
Interval 25.0 to 100.0
|
SECONDARY outcome
Timeframe: 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 .
Outcome measures
| Measure |
Subcuticular Suture
n=97 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=99 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic
Alternative oral analgesic
|
6 participants
|
9 participants
|
|
Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic
Patient-controlled analgesia
|
5 participants
|
6 participants
|
|
Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic
Single dose IV/IM analgesic
|
16 participants
|
22 participants
|
SECONDARY outcome
Timeframe: At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointmentPopulation: 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.
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).
Outcome measures
| Measure |
Subcuticular Suture
n=59 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=69 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Patient Satisfaction
Appearance of incision: positive
|
55 participants
|
63 participants
|
|
Patient Satisfaction
Would recommend: negative
|
11 participants
|
6 participants
|
|
Patient Satisfaction
Overall satisfaction: negative
|
4 participants
|
2 participants
|
|
Patient Satisfaction
Overall satisfaction: positive
|
55 participants
|
67 participants
|
|
Patient Satisfaction
Appearance of incision: negative
|
3 participants
|
6 participants
|
|
Patient Satisfaction
Would recommend: positive
|
48 participants
|
63 participants
|
|
Patient Satisfaction
Willingness (again): negative
|
8 participants
|
7 participants
|
|
Patient Satisfaction
Willingness (again): positive
|
51 participants
|
61 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Subcuticular Suture
n=91 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=96 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Surgeon Satisfaction (Per Procedure)
Appearance of incision: negativ
|
6 Surgeons reporting per category
|
7 Surgeons reporting per category
|
|
Surgeon Satisfaction (Per Procedure)
Appearance of incision: positive
|
85 Surgeons reporting per category
|
89 Surgeons reporting per category
|
|
Surgeon Satisfaction (Per Procedure)
Recommend: negative
|
14 Surgeons reporting per category
|
3 Surgeons reporting per category
|
|
Surgeon Satisfaction (Per Procedure)
Recommend: positive
|
77 Surgeons reporting per category
|
93 Surgeons reporting per category
|
|
Surgeon Satisfaction (Per Procedure)
Willingness to use again: negative
|
16 Surgeons reporting per category
|
2 Surgeons reporting per category
|
|
Surgeon Satisfaction (Per Procedure)
Willingness to use again: positive
|
75 Surgeons reporting per category
|
94 Surgeons reporting per category
|
SECONDARY outcome
Timeframe: Measured at 6 week postoperative appointmentPopulation: 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.
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.
Outcome measures
| Measure |
Subcuticular Suture
n=44 Participants
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=52 Participants
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Cosmetic Outcome
Patient: scar more irregular
|
4.4 units on a scale
Interval 2.0 to 6.0
|
3.6 units on a scale
Interval 1.0 to 5.5
|
|
Cosmetic Outcome
Patient: scar overall opinion
|
4.4 units on a scale
Interval 3.0 to 6.0
|
3.8 units on a scale
Interval 2.0 to 5.0
|
|
Cosmetic Outcome
Observer: relief
|
2.5 units on a scale
Interval 1.0 to 3.0
|
2.6 units on a scale
Interval 2.0 to 3.0
|
|
Cosmetic Outcome
Observer: overall opinion
|
2.8 units on a scale
Interval 2.0 to 3.0
|
2.6 units on a scale
Interval 2.0 to 3.0
|
|
Cosmetic Outcome
Patient: scar painful
|
2.2 units on a scale
Interval 1.0 to 3.0
|
1.8 units on a scale
Interval 1.0 to 2.0
|
|
Cosmetic Outcome
Patient: scar itching
|
2.2 units on a scale
Interval 1.0 to 3.0
|
1.9 units on a scale
Interval 1.0 to 3.0
|
|
Cosmetic Outcome
Patient: scar color is different
|
5.3 units on a scale
Interval 2.0 to 8.0
|
3.9 units on a scale
Interval 1.5 to 6.0
|
|
Cosmetic Outcome
Patient: scar stiffness is different
|
5.0 units on a scale
Interval 2.0 to 8.0
|
3.7 units on a scale
Interval 2.0 to 6.0
|
|
Cosmetic Outcome
Patient: scar thickness is different
|
4.6 units on a scale
Interval 2.0 to 7.5
|
4.0 units on a scale
Interval 1.5 to 6.5
|
|
Cosmetic Outcome
Observer: vascularity
|
2.9 units on a scale
Interval 2.0 to 4.0
|
2.8 units on a scale
Interval 2.0 to 3.0
|
|
Cosmetic Outcome
Observer: pigmentation
|
3.2 units on a scale
Interval 2.0 to 4.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Cosmetic Outcome
Observer: thickness
|
2.7 units on a scale
Interval 2.0 to 3.0
|
2.6 units on a scale
Interval 2.0 to 3.0
|
|
Cosmetic Outcome
Observer: pliability
|
2.7 units on a scale
Interval 1.0 to 4.0
|
2.8 units on a scale
Interval 2.0 to 3.0
|
|
Cosmetic Outcome
Observer: surface area
|
2.5 units on a scale
Interval 2.0 to 3.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
Adverse Events
Subcuticular Suture
Subcuticular Staple
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subcuticular Suture
n=93 participants at risk
Subcuticular suture has been used for many years to close skin incisions.
|
Subcuticular Staple
n=96 participants at risk
Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Staple expulsion or suture trimming
|
0.00%
0/93 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
3.1%
3/96 • Number of events 3 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
|
Pregnancy, puerperium and perinatal conditions
Surgical Site Infection
|
4.3%
4/93 • Number of events 4 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
0.00%
0/96 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
|
Pregnancy, puerperium and perinatal conditions
Superficial Wound Separation
|
4.3%
4/93 • Number of events 4 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
1.0%
1/96 • Number of events 1 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
|
Pregnancy, puerperium and perinatal conditions
Seroma
|
1.1%
1/93 • Number of events 1 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
0.00%
0/96 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
|
Pregnancy, puerperium and perinatal conditions
Hematoma
|
0.00%
0/93 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
2.1%
2/96 • Number of events 2 • Post operative complications were collected from December 2012 through June 2014.
Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place