Seprafilm® for Prevention of Adhesions at Repeat Cesarean

NCT00697606 | Terminated Phase 3 DMC

• 1 other identifier: Study #08-032
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesion Formation After Primary Cesarean Delivery

Keywords

Seprafilm®; cesarean; adhesions; primary; repeat

Outcome Measures

Primary Outcomes (1)

• To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean.

  at repeat cesarean

Secondary Outcomes (4)

• 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

Study Arms (2)

A

EXPERIMENTAL

Seprafilm®

Device: Seprafilm®

B

SHAM COMPARATOR

Control

Other: Control

Interventions

Seprafilm® DEVICE

Seprafilm® placed at time of primary cesarean

A

Control OTHER

no Seprafilm® used at primary cesarean

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women after 24 weeks' gestation.
• First cesarean delivery.
• Age \> 18 years.
• Cesarean to be performed by a participating surgeon.
• Non-closure of the visceral or parietal peritoneum.

You may not qualify if:

• Any prior abdominal surgery including prior cesarean, laparoscopy, appendectomy, cholecystectomy or any uterine adnexal or bowel surgery.
• Clinical diagnosis of chorioamnionitis.
• Women having tubal ligation at the time of primary cesarean.
• Inability to obtain informed consent.

Sponsors & Collaborators

• Abington Memorial Hospital: lead

Study Sites (1)

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 16, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

US (1)