Trial Outcomes & Findings for Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery (NCT NCT02466776)
NCT ID: NCT02466776
Last Updated: 2024-01-09
Results Overview
Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
238 participants
Primary outcome timeframe
At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum
Results posted on
2024-01-09
Participant Flow
Participant milestones
| Measure |
Stainless Steel Staples
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
|
Absorbable Subcuticular Suture
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
119
|
|
Overall Study
COMPLETED
|
119
|
119
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Absorbable Subcuticular Suture
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
|
Stainless Steel Staples
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
31.4 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
31.25 years
STANDARD_DEVIATION 0.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
68 participants
n=5 Participants
|
59 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=5 Participants
|
119 participants
n=7 Participants
|
238 participants
n=5 Participants
|
|
Married/partner
|
69 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
College Graduate
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Private Insurance
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Singleton Gestation
|
111 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Gestational age at delivery
|
38.8 Weeks
STANDARD_DEVIATION 1.9 • n=5 Participants
|
38.2 Weeks
STANDARD_DEVIATION 2.5 • n=7 Participants
|
38.5 Weeks
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Number of previous cesarean delivery (CD)
o
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Number of previous cesarean delivery (CD)
1
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Number of previous cesarean delivery (CD)
2 or more
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Time since last cesarean delivery (CD)
No history of prior cesarean delivery (CD)
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Time since last cesarean delivery (CD)
Within 5 years
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Time since last cesarean delivery (CD)
More than 5 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Diabetes
None
|
82 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Diabetes
Pre-gestational
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Diabetes
Gestational
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Hypertensive Disease
None
|
85 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Hypertensive Disease
Pre-gestational
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Hypertensive Disease
Gestational
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Hypertensive Disease
Preeclampsia
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Tobacco use
None
|
96 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Tobacco use
Current
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Tobacco use
Past
|
16 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Chorioamnionitis
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartumPopulation: The last 2 rows show the rate of healed versus non-healed wound complications out of the total number of wound complications diagnosed in the staples group (n=8) and suture group (n=5).
Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=118 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Composite wound complication
|
8 Participants
|
5 Participants
|
15 Participants
|
16 Participants
|
23 Participants
|
21 Participants
|
|
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Infection
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Superficial separation
|
7 Participants
|
3 Participants
|
11 Participants
|
11 Participants
|
15 Participants
|
14 Participants
|
|
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Deep separation
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Infection and separation
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Healed at 6 weeks
|
6 Participants
|
4 Participants
|
12 Participants
|
11 Participants
|
—
|
—
|
|
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Not healed at 6 weeks
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of surgery and hospitalizationDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Number of Participants According to Skin Incision
Skin incision: Pfannenstiel
|
114 Participants
|
118 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Skin Incision
Skin incision: Midline vertical
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of surgeryDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Operating Surgeon Level
Surgeon level: Attending/Fellow
|
67 Participants
|
66 Participants
|
—
|
—
|
—
|
—
|
|
Operating Surgeon Level
Surgeon level: Resident
|
52 Participants
|
53 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of surgeryDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Surgical Assistant Level
Assistant Level: Attending/Fellow
|
101 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
|
Surgical Assistant Level
Assistant Level: Resident
|
18 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of surgery and hospitalizationDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Total Operative Time
|
43.4 minutes
Standard Deviation 21.9
|
55.8 minutes
Standard Deviation 26
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of surgeryDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Total Blood Loss
|
773 mL
Standard Deviation 432
|
837 mL
Standard Deviation 447
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of surgery and hospitalizationDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Blood Transfusion
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of surgery (pre-delivery) and post-deliveryDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Change in Hemoglobin (Pre-delivery and Post-delivery)
|
1.68 Change in grams of hemoglobin
Standard Deviation 1.5
|
1.93 Change in grams of hemoglobin
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of deliveryDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Neonatal Birthweight
|
3406 grams
Standard Deviation 878
|
3426 grams
Standard Deviation 711
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of deliveryDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable The Apgar score, developed by Virginia Apgar describes the condition of the newborn infant immediately after birth and, when properly applied, is a tool for standardized assessment 18. It also provides a mechanism to record fetal-to-neonatal transition. This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The Apgar score ranges from 0 (lowest, poor outcome) to 10 (highest, good outcome).
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Number of Participants With 5 Minute Apgar Score <7
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During hospitalizationDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Number of Participants Receiving Postpartum Prophylactic Anticoagulation
|
66 Participants
|
74 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of surgery and hospitalizationDate were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=119 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=119 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Total Length of Hospital Stay
|
4.9 days
Standard Deviation 0.9
|
4.9 days
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 2 weeks postpartumPatients' pain associated with their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their pain on a scale of 0 (no pain) to 10 (worst pain).
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=113 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=114 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Patient Pain Score (From 1 to 10)
|
2 Score on a scale
Interval 1.0 to 3.0
|
2 Score on a scale
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At time of hospital discharge and at 2 weeks postpartumPatients' satisfaction with the healing of their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their overall satisfaction with their wound healing and appearance (1=least satisfied, 10=most satisfied). Patients were also asked to rate their concern regarding their wound healing (1= least concerned and 10 = most concerned).
Outcome measures
| Measure |
Stainless Steel Staples at HOSPITAL DISCHARGE
n=113 Participants
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at HOSPITAL DISCHARGE
n=114 Participants
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
Stainless Steel Staples at 2 WEEKS POSTPARTUM
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section
|
Stainless Steel Staples TOTAL WOUND COMPLICATIONS
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean section.
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean section.
|
Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
|
|---|---|---|---|---|---|---|
|
Patient Satisfaction With Wound Healing and Appearance
Wound appearance satisfaction (1=least, 10=most)
|
10 Score on a scale
Interval 9.0 to 10.0
|
10 Score on a scale
Interval 9.0 to 10.0
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction With Wound Healing and Appearance
Concern about wound healing (1=least, 10=most)
|
1 Score on a scale
Interval 1.0 to 2.0
|
1 Score on a scale
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
Adverse Events
Stainless Steel Staples
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Absorbable Subcuticular Suture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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