Trial Outcomes & Findings for A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section) (NCT NCT01198691)
NCT ID: NCT01198691
Last Updated: 2018-10-09
Results Overview
Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.
COMPLETED
PHASE2
100 participants
1 Year
2018-10-09
Participant Flow
Participant milestones
| Measure |
Control Group
This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
|
Case Group
This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples
|
|---|---|---|
|
Completed Surgery -Received Intervention
STARTED
|
50
|
50
|
|
Completed Surgery -Received Intervention
COMPLETED
|
50
|
50
|
|
Completed Surgery -Received Intervention
NOT COMPLETED
|
0
|
0
|
|
Completed VAS Score Postop Day 1
STARTED
|
50
|
50
|
|
Completed VAS Score Postop Day 1
COMPLETED
|
47
|
46
|
|
Completed VAS Score Postop Day 1
NOT COMPLETED
|
3
|
4
|
|
Completed VAS Score at Discharge
STARTED
|
50
|
50
|
|
Completed VAS Score at Discharge
COMPLETED
|
45
|
44
|
|
Completed VAS Score at Discharge
NOT COMPLETED
|
5
|
6
|
|
Survey Prior to Discharge
STARTED
|
50
|
50
|
|
Survey Prior to Discharge
COMPLETED
|
18
|
17
|
|
Survey Prior to Discharge
NOT COMPLETED
|
32
|
33
|
|
6 Week Post-partum Survey
STARTED
|
50
|
50
|
|
6 Week Post-partum Survey
COMPLETED
|
21
|
26
|
|
6 Week Post-partum Survey
NOT COMPLETED
|
29
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)
Baseline characteristics by cohort
| Measure |
Control Group
n=50 Participants
This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
|
Case Group
n=50 Participants
This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.32 years
STANDARD_DEVIATION 5.63 • n=99 Participants
|
27.38 years
STANDARD_DEVIATION 6.15 • n=107 Participants
|
27.85 years
STANDARD_DEVIATION 5.89 • n=206 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
22 participants
n=99 Participants
|
23 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
24 participants
n=99 Participants
|
26 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 YearPost operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.
Outcome measures
| Measure |
Control Group
n=47 Participants
This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
|
Case Group
n=46 Participants
This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples
|
|---|---|---|
|
Post Operative Pain
|
2.56 units on a scale
Standard Error 1.47
|
2.90 units on a scale
Standard Error 1.54
|
PRIMARY outcome
Timeframe: 1 YearPost operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.
Outcome measures
| Measure |
Control Group
n=45 Participants
This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
|
Case Group
n=44 Participants
This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples
|
|---|---|---|
|
Post Operative Pain (3 Days Post-op)
|
2.66 units on a scale
Standard Deviation 1.47
|
3.52 units on a scale
Standard Deviation 5.80
|
SECONDARY outcome
Timeframe: This will be assessed 3 day after the patient's C-section before they are discharged from the hospitalPatients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients "strongly agree," "agree," "disagree," or "strongly disagree" with the statement, "I am satisfied with the overall appearance of my incision." Those who responsed "agree" or "strongly agree" were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied.
Outcome measures
| Measure |
Control Group
n=18 Participants
This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
|
Case Group
n=17 Participants
This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples
|
|---|---|---|
|
Patient Satisfaction
|
16 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Patient satisfaction will be assessed 6 weeks later at their post-op visitPatients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients "strongly agree," "agree," "disagree," or "strongly disagree" with the statement, "I am satisfied with the overall appearance of my incision." Those who responsed "agree" or "strongly agree" were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied.
Outcome measures
| Measure |
Control Group
n=21 Participants
This group will receive the standard metallic staples to close their incision.
Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
|
Case Group
n=26 Participants
This group will receive the Insorb absorbable staples to close their incision.
Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples
|
|---|---|---|
|
Patient Satisfaction
|
20 participants
|
21 participants
|
Adverse Events
Control Group
Case Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place