Trial Outcomes & Findings for Seprafilm® Adhesion Barrier and Cesarean Delivery (NCT NCT00565643)
NCT ID: NCT00565643
Last Updated: 2024-05-14
Results Overview
The Percentage of participants with one or more adhesions, regardless of the extent or severity
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
753 participants
Primary outcome timeframe
3 to 5 years
Results posted on
2024-05-14
Participant Flow
Participant milestones
| Measure |
HA-CMC Group
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
Placebo: Routine abdominal closure without placement of adhesion barrier
|
|---|---|---|
|
Overall Study
STARTED
|
380
|
373
|
|
Overall Study
Safety Data
|
380
|
373
|
|
Overall Study
Primary Outcome (Subsequent Cesarean)
|
80
|
92
|
|
Overall Study
COMPLETED
|
380
|
373
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seprafilm® Adhesion Barrier and Cesarean Delivery
Baseline characteristics by cohort
| Measure |
HA-CMC Group
n=380 Participants
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
n=373 Participants
Placebo: Routine abdominal closure without placement of adhesion barrier
|
Total
n=753 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.4 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
30.9 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
380 Participants
n=5 Participants
|
373 Participants
n=7 Participants
|
753 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
380 participants
n=5 Participants
|
373 participants
n=7 Participants
|
753 participants
n=5 Participants
|
|
Gravid
|
2 pregnancies
n=5 Participants
|
2 pregnancies
n=7 Participants
|
NA pregnancies
n=5 Participants
|
|
Parity
|
1 pregnancies
n=5 Participants
|
1 pregnancies
n=7 Participants
|
NA pregnancies
n=5 Participants
|
|
Gestational age (weeks)
|
38.7 weeks
STANDARD_DEVIATION 1.9 • n=5 Participants
|
38.1 weeks
STANDARD_DEVIATION 3.9 • n=7 Participants
|
NA weeks
STANDARD_DEVIATION NA • n=5 Participants
|
|
Body Mass Index (BMI), kg/m^2
|
33.3 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
33.2 kg/m^2
STANDARD_DEVIATION 7.8 • n=7 Participants
|
NA kg/m^2
STANDARD_DEVIATION NA • n=5 Participants
|
|
# of previous cesarean births
|
1 births
n=5 Participants
|
1 births
n=7 Participants
|
NA births
n=5 Participants
|
|
Preoperative Hematocrit
|
34.8 percent
STANDARD_DEVIATION 4.3 • n=5 Participants
|
34.4 percent
STANDARD_DEVIATION 5.0 • n=7 Participants
|
NA percent
STANDARD_DEVIATION NA • n=5 Participants
|
|
Preoperative White Blood cell count
|
10.3 cells/mm^3
STANDARD_DEVIATION 3.4 • n=5 Participants
|
10.7 cells/mm^3
STANDARD_DEVIATION 4.6 • n=7 Participants
|
NA cells/mm^3
STANDARD_DEVIATION NA • n=5 Participants
|
|
Preoperative Maximum Temperature
|
97.8 degrees Fahrenheit
STANDARD_DEVIATION 1.0 • n=5 Participants
|
97.9 degrees Fahrenheit
STANDARD_DEVIATION 0.9 • n=7 Participants
|
NA degrees Fahrenheit
STANDARD_DEVIATION NA • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 to 5 yearsThe Percentage of participants with one or more adhesions, regardless of the extent or severity
Outcome measures
| Measure |
HA-CMC Group
n=80 Participants
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
n=92 Participants
Placebo: Routine abdominal closure without placement of adhesion barrier
|
|---|---|---|
|
Incidence of Adhesions
|
75.6 percentage of patients with adhesions
|
75.9 percentage of patients with adhesions
|
PRIMARY outcome
Timeframe: 3 to 5 yearsAdhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site).
Outcome measures
| Measure |
HA-CMC Group
n=80 Participants
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
n=92 Participants
Placebo: Routine abdominal closure without placement of adhesion barrier
|
|---|---|---|
|
Adhesion Score
|
2 units on a scale
Interval 0.0 to 10.0
|
2 units on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: 1 to 5 yearsHemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups
Outcome measures
| Measure |
HA-CMC Group
n=380 Participants
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
n=373 Participants
Placebo: Routine abdominal closure without placement of adhesion barrier
|
|---|---|---|
|
Post-operative Hemoglobin
|
29.9 % of blood that is red blood cells
Standard Deviation 4.1
|
30.2 % of blood that is red blood cells
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 1 to 5 yearsPost-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups
Outcome measures
| Measure |
HA-CMC Group
n=380 Participants
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
n=373 Participants
Placebo: Routine abdominal closure without placement of adhesion barrier
|
|---|---|---|
|
Post-operative White Blood Cell Count
|
11.3 cells/mm^3
Standard Deviation 6.4
|
11.0 cells/mm^3
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 1 to 5 yearsPercentage of patients experiencing any of the predefined post-operative complications following randomization
Outcome measures
| Measure |
HA-CMC Group
n=380 Participants
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
n=373 Participants
Placebo: Routine abdominal closure without placement of adhesion barrier
|
|---|---|---|
|
Post-Operative Complications
Any complication
|
6.3 % of patients experiencing complication
|
4.0 % of patients experiencing complication
|
|
Post-Operative Complications
Fever
|
4.5 % of patients experiencing complication
|
3.0 % of patients experiencing complication
|
|
Post-Operative Complications
Ileus or bowel obstruction
|
0 % of patients experiencing complication
|
0 % of patients experiencing complication
|
|
Post-Operative Complications
Any wound complication
|
2.1 % of patients experiencing complication
|
0.8 % of patients experiencing complication
|
|
Post-Operative Complications
Venous thromboembolism
|
0 % of patients experiencing complication
|
0.3 % of patients experiencing complication
|
|
Post-Operative Complications
Readmission (<=6 weeks postpartum)
|
1.3 % of patients experiencing complication
|
0.5 % of patients experiencing complication
|
SECONDARY outcome
Timeframe: 1 to 5 yearsMaximum temperature of patient, \>24 hours following randomization delivery
Outcome measures
| Measure |
HA-CMC Group
n=380 Participants
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
n=373 Participants
Placebo: Routine abdominal closure without placement of adhesion barrier
|
|---|---|---|
|
Post-operative Maximum Temperature Following Randomization
|
98.2 degrees Fahrenheit
Standard Deviation 1.0
|
98.2 degrees Fahrenheit
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 3 to 5 yearsAmount of time spent at the time of the subsequent delivery
Outcome measures
| Measure |
HA-CMC Group
n=80 Participants
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
n=92 Participants
Placebo: Routine abdominal closure without placement of adhesion barrier
|
|---|---|---|
|
Operative Times at Subsequent Delivery
Skin-to-delivery
|
13 minutes
Interval 3.0 to 70.0
|
13 minutes
Interval 4.0 to 55.0
|
|
Operative Times at Subsequent Delivery
Total operative time
|
51 minutes
Interval 23.0 to 175.0
|
54 minutes
Interval 26.0 to 157.0
|
Adverse Events
HA-CMC Group
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Closure Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HA-CMC Group
n=380 participants at risk
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
|
Routine Closure Group
n=373 participants at risk
Placebo: Routine abdominal closure without placement of adhesion barrier
|
|---|---|---|
|
Infections and infestations
Readmission for Infection
|
0.53%
2/380 • Number of events 2 • From time of enrollment through 8 weeks following randomization
|
0.27%
1/373 • Number of events 1 • From time of enrollment through 8 weeks following randomization
|
|
Gastrointestinal disorders
Readmission for Intra-abdominal complication
|
0.53%
2/380 • Number of events 2 • From time of enrollment through 8 weeks following randomization
|
0.00%
0/373 • From time of enrollment through 8 weeks following randomization
|
|
Nervous system disorders
Readmission for Central nervous system problem
|
0.00%
0/380 • From time of enrollment through 8 weeks following randomization
|
0.27%
1/373 • Number of events 1 • From time of enrollment through 8 weeks following randomization
|
|
Pregnancy, puerperium and perinatal conditions
Readmission for obstetrical complications
|
0.26%
1/380 • Number of events 1 • From time of enrollment through 8 weeks following randomization
|
0.00%
0/373 • From time of enrollment through 8 weeks following randomization
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place