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Seprafilm® Adhesion Barrier and Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00565643
Recruitment Status : Completed
First Posted : November 30, 2007
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Collaborators:
Stony Brook University
Lehigh Valley Hospital
Information provided by (Responsible Party):
Daniel Kiefer, Winthrop University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Adhesions
Cesarean Section
Delivery, Obstetric
Interventions Device: modified sodium hyaluronic acid and carboxymethylcellulose
Device: Placebo
Enrollment 753
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HA-CMC Group Routine Closure Group
Hide Arm/Group Description modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery Placebo: Routine abdominal closure without placement of adhesion barrier
Period Title: Overall Study
Started 380 373
Safety Data 380 373
Primary Outcome (Subsequent Cesarean) 80 92
Completed 380 373
Not Completed 0 0
Arm/Group Title HA-CMC Group Routine Closure Group Total
Hide Arm/Group Description modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery Placebo: Routine abdominal closure without placement of adhesion barrier Total of all reporting groups
Overall Number of Baseline Participants 380 373 753
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 380 participants 373 participants 753 participants
30.4  (5.1) 30.9  (5.3) NA [1]   (NA)
[1]
The Totals are unable to be calculated because the analysis was not performed for the Total population and there are no means to calculate.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 380 participants 373 participants 753 participants
Female
380
 100.0%
373
 100.0%
753
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 380 participants 373 participants 753 participants
380 373 753
Gravid  
Mean (Full Range)
Unit of measure:  Pregnancies
Number Analyzed 380 participants 373 participants 753 participants
2
(1 to 20)
2
(1 to 11)
NA [1] 
(NA to NA)
[1]
The Totals are unable to be calculated because the analysis was not performed for the Total population and there are no means to calculate.
Parity  
Median (Full Range)
Unit of measure:  Pregnancies
Number Analyzed 380 participants 373 participants 753 participants
1
(0 to 4)
1
(0 to 4)
NA [1] 
(NA to NA)
[1]
The Totals are unable to be calculated because the analysis was not performed for the Total population and there are no means to calculate.
Gestational age (weeks)  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 380 participants 373 participants 753 participants
38.7  (1.9) 38.1  (3.9) NA [1]   (NA)
[1]
The Totals are unable to be calculated because the analysis was not performed for the Total population and there are no means to calculate.
Body Mass Index (BMI), kg/m^2  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 380 participants 373 participants 753 participants
33.3  (6.6) 33.2  (7.8) NA [1]   (NA)
[1]
The Totals are unable to be calculated because the analysis was not performed for the Total population and there are no means to calculate.
# of previous cesarean births  
Median (Full Range)
Unit of measure:  Births
Number Analyzed 380 participants 373 participants 753 participants
1
(0 to 3)
1
(0 to 3)
NA [1] 
(NA to NA)
[1]
The Totals are unable to be calculated because the analysis was not performed for the Total population and there are no means to calculate.
Preoperative Hematocrit  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 380 participants 373 participants 753 participants
34.8  (4.3) 34.4  (5.0) NA [1]   (NA)
[1]
The Totals are unable to be calculated because the analysis was not performed for the Total population and there are no means to calculate.
Preoperative White Blood cell count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 380 participants 373 participants 753 participants
10.3  (3.4) 10.7  (4.6) NA [1]   (NA)
[1]
The Totals are unable to be calculated because the analysis was not performed for the Total population and there are no means to calculate.
Preoperative Maximum Temperature  
Mean (Standard Deviation)
Unit of measure:  Degrees Fahrenheit
Number Analyzed 380 participants 373 participants 753 participants
97.8  (1.0) 97.9  (0.9) NA [1]   (NA)
[1]
The Totals are unable to be calculated because the analysis was not performed for the Total population and there are no means to calculate.
1.Primary Outcome
Title Incidence of Adhesions
Hide Description The Percentage of participants with one or more adhesions, regardless of the extent or severity
Time Frame 3 to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HA-CMC Group Routine Closure Group
Hide Arm/Group Description:
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
Placebo: Routine abdominal closure without placement of adhesion barrier
Overall Number of Participants Analyzed 80 92
Measure Type: Number
Unit of Measure: percentage of patients with adhesions
75.6 75.9
2.Primary Outcome
Title Adhesion Score
Hide Description Adhesion 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).
Time Frame 3 to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HA-CMC Group Routine Closure Group
Hide Arm/Group Description:
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
Placebo: Routine abdominal closure without placement of adhesion barrier
Overall Number of Participants Analyzed 80 92
Median (Full Range)
Unit of Measure: units on a scale
2
(0 to 10)
2
(0 to 8)
3.Secondary Outcome
Title Post-operative Hemoglobin
Hide Description Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups
Time Frame 1 to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HA-CMC Group Routine Closure Group
Hide Arm/Group Description:
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
Placebo: Routine abdominal closure without placement of adhesion barrier
Overall Number of Participants Analyzed 380 373
Mean (Standard Deviation)
Unit of Measure: % of blood that is red blood cells
29.9  (4.1) 30.2  (3.6)
4.Secondary Outcome
Title Post-operative White Blood Cell Count
Hide Description Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups
Time Frame 1 to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HA-CMC Group Routine Closure Group
Hide Arm/Group Description:
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
Placebo: Routine abdominal closure without placement of adhesion barrier
Overall Number of Participants Analyzed 380 373
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
11.3  (6.4) 11.0  (3.3)
5.Secondary Outcome
Title Post-Operative Complications
Hide Description Percentage of patients experiencing any of the predefined post-operative complications following randomization
Time Frame 1 to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HA-CMC Group Routine Closure Group
Hide Arm/Group Description:
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
Placebo: Routine abdominal closure without placement of adhesion barrier
Overall Number of Participants Analyzed 380 373
Measure Type: Number
Unit of Measure: % of patients experiencing complication
Any complication 6.3 4.0
Fever 4.5 3.0
Ileus or bowel obstruction 0 0
Any wound complication 2.1 0.8
Venous thromboembolism 0 0.3
Readmission (<=6 weeks postpartum) 1.3 0.5
6.Secondary Outcome
Title Post-operative Maximum Temperature Following Randomization
Hide Description Maximum temperature of patient, >24 hours following randomization delivery
Time Frame 1 to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HA-CMC Group Routine Closure Group
Hide Arm/Group Description:
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
Placebo: Routine abdominal closure without placement of adhesion barrier
Overall Number of Participants Analyzed 380 373
Mean (Standard Deviation)
Unit of Measure: degrees Fahrenheit
98.2  (1.0) 98.2  (0.9)
7.Secondary Outcome
Title Operative Times at Subsequent Delivery
Hide Description Amount of time spent at the time of the subsequent delivery
Time Frame 3 to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HA-CMC Group Routine Closure Group
Hide Arm/Group Description:
modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
Placebo: Routine abdominal closure without placement of adhesion barrier
Overall Number of Participants Analyzed 80 92
Median (Full Range)
Unit of Measure: minutes
Skin-to-delivery
13
(3 to 70)
13
(4 to 55)
Total operative time
51
(23 to 175)
54
(26 to 157)
Time Frame From time of enrollment through 8 weeks following randomization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HA-CMC Group Routine Closure Group
Hide Arm/Group Description modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery Placebo: Routine abdominal closure without placement of adhesion barrier
All-Cause Mortality
HA-CMC Group Routine Closure Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
HA-CMC Group Routine Closure Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/380 (1.32%)      2/373 (0.54%)    
Gastrointestinal disorders     
Readmission for Intra-abdominal complication   2/380 (0.53%)  2 0/373 (0.00%)  0
Infections and infestations     
Readmission for Infection   2/380 (0.53%)  2 1/373 (0.27%)  1
Nervous system disorders     
Readmission for Central nervous system problem   0/380 (0.00%)  0 1/373 (0.27%)  1
Pregnancy, puerperium and perinatal conditions     
Readmission for obstetrical complications  [1]  1/380 (0.26%)  1 0/373 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Delayed Postpartum hemorrhage
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HA-CMC Group Routine Closure Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/380 (0.00%)      0/373 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Kiefer
Organization: Lehigh Valley Health Network
Phone: 484-664-7521
EMail: daniel_g.kiefer@lvhn.org
Layout table for additonal information
Responsible Party: Daniel Kiefer, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00565643    
Other Study ID Numbers: IRB No. 07023
MO1RR10710 ( Other Grant/Funding Number: General Clinical Research Center (GCRC) )
First Submitted: November 29, 2007
First Posted: November 30, 2007
Results First Submitted: December 30, 2015
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016