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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Adhesion Formation After Primary Cesarean Delivery	Device: Seprafilm®; Other: Control	Phase 3

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	450 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Randomized Double-Blind Controlled Study to Determine if Seprafilm® Reduces Adhesions After Primary Cesarean Section
Study Start Date :	July 2008
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	June 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean. [ Time Frame: at repeat cesarean ]

Secondary Outcome Measures :

1. To determine to what extent Seprafilm® decreases the incidence of adhesion formation. [ Time Frame: at repeat cesarean ]
2. To determine the incidence of adhesion formation during repeat cesarean delivery. [ Time Frame: at repeat cesarean ]
3. 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 ]
4. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	David Peleg, MD, Principle Investigator, Abington Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00697606 History of Changes
Other Study ID Numbers:	Study #08-032
First Posted:	June 16, 2008
Last Update Posted:	December 30, 2015
Last Verified:	December 2015

Keywords provided by David Peleg, MD, Abington Memorial Hospital:

Seprafilm®; cesarean; adhesions; primary; repeat

Additional relevant MeSH terms:

Tissue Adhesions; Cicatrix; Fibrosis; Pathologic Processes; Hyaluronic Acid	Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents