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

A

Abington Memorial Hospital

Status and phase

Terminated
Phase 3

Conditions

Adhesion Formation After Primary Cesarean Delivery

Treatments

Device: Seprafilm®
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT00697606
Study #08-032

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

450 participants in 2 patient groups

A
Experimental group
Description:
Seprafilm®
Treatment:
Device: Seprafilm®
B
Sham Comparator group
Description:
Control
Treatment:
Other: Control

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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