Expired Study
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Abington, Pennsylvania 19001


Purpose:

Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. Limited data is available on the effectiveness of Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. The objective of this definitive project is to define the extent of reduction of adhesion formation of Seprafilm® when used at the time of primary cesarean section. Women undergoing primary cesarean section will be randomized for Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.


Study summary:

This is a prospective randomized double-blinded study. Patients will be randomized prior to primary cesarean section to either the study arm (Seprafilm® placement) or control arm (nothing placed). Seprafilm® will be placed over the repaired uterine incision and over the anterior aspect of the uterus prior to closure of the fascia (2 to 3 sheets per patient). Randomization will be by opaque envelops containing group assignment. Participants and surgeons will be blinded to group designation at the time of repeat cesarean. The surgeon will be asked to grade the adhesions at the time of repeat cesarean.


Criteria:

Inclusion Criteria: 1. Pregnant women after 24 weeks' gestation. 2. First cesarean delivery. 3. Age > 18 years. 4. Cesarean to be performed by a participating surgeon. 5. Non-closure of the visceral or parietal peritoneum. Exclusion Criteria: 1. Any prior abdominal surgery including prior cesarean, laparoscopy, appendectomy, cholecystectomy or any uterine adnexal or bowel surgery. 2. Clinical diagnosis of chorioamnionitis. 3. Women having tubal ligation at the time of primary cesarean. 4. Inability to obtain informed consent.


Study is Available At:


Original ID:

Study #08-032


NCT ID:

NCT00697606


Secondary ID:


Study Acronym:

SPARC


Brief Title:

Seprafilm® for Prevention of Adhesions at Repeat Cesarean


Official Title:

Randomized Double-Blind Controlled Study to Determine if Seprafilm® Reduces Adhesions After Primary Cesarean Section


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abington Memorial Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

lack of funding


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

450


Enrollment Type:

Actual


Overall Contact Information

Official Name:Amy Mackey, MD
Principal Investigator
Abington Memorial Hospital

Study Dates

Start Date:July 2008
Completion Date:June 2011
Completion Type:Actual
Primary Completion Date:June 2011
Primary Completion Type:Actual
Verification Date:December 2015
Last Changed Date:December 29, 2015
First Received Date:June 12, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To determine the incidence of fertility issues in women having Seprafilm® placed during primary cesarean delivery versus those not having Seprafilm® placed. Participating women will be contacted by telephone every 4 months.
Time Frame:ongoing during trial
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To evaluate complication rates in those with Seprafilm® versus those without during repeat surgery by examining length of operating times, blood loss, bladder injuries, and Apgar scores
Time Frame:at repeat cesarean
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:To determine the incidence of adhesion formation during repeat cesarean delivery.
Time Frame:at repeat cesarean
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To determine to what extent Seprafilm® decreases the incidence of adhesion formation.
Time Frame:at repeat cesarean
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean.
Time Frame:at repeat cesarean
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Seprafilm®
Description:Seprafilm® placed at time of primary cesarean
Arm Name:A
Intervention Type:Other
Name:Control
Description:no Seprafilm® used at primary cesarean
Arm Name:B

Study Arms

Study Arm Type:Sham Comparator
Arm Name:B
Description:Control
Study Arm Type:Experimental
Arm Name:A
Description:Seprafilm®

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Abington Memorial Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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