Seprafilm® for Prevention of Adhesions at Repeat Cesarean (SPARC)

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

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 Overview

• Status: Terminated
• Conditions: Adhesion Formation After Primary Cesarean Delivery
• Intervention / Treatment: Device: Seprafilm®; Other: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Seprafilm®	Device: Seprafilm®; Seprafilm® placed at time of primary cesarean
Sham Comparator: B; Control	Other: Control; no Seprafilm® used at primary cesarean

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean.	at repeat cesarean

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine to what extent Seprafilm® decreases the incidence of adhesion formation.	at repeat cesarean
To determine the incidence of adhesion formation during repeat cesarean delivery.	at repeat cesarean
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	at repeat cesarean
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.	ongoing during trial

Collaborators and Investigators

• Sponsor: Abington Memorial Hospital
• Investigators: Principal Investigator: Amy Mackey, MD, Abington Memorial Hospital; Principal Investigator: Mark Shahin, MD, Abington Memorial Hospital; Principal Investigator: Richard Latta, MD, Abington Memorial Hospital; Principal Investigator: David Peleg, MD, Abington Memorial Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 12, 2008
• First Submitted That Met QC Criteria: June 12, 2008
• First Posted (Estimate): June 16, 2008

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: primary; adhesions; cesarean; Seprafilm®; repeat
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: Study #08-032