Seprafilm® for Prevention of Adhesions at Repeat Cesarean - Full Text View

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.

Condition	Intervention	Phase
Adhesion Formation After Primary Cesarean Delivery	Device: Seprafilm® Other: Control	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Adhesions Cesarean Section

U.S. FDA Resources

Further study details as provided by David Peleg, MD, Abington Memorial Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	450
Study Start Date:	July 2008
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Seprafilm®	Device: Seprafilm® Seprafilm® placed at time of primary cesarean
Sham Comparator: B Control	Other: Control no Seprafilm® used at primary cesarean

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.

Eligibility


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

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697606

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


Responsible Party:	David Peleg, MD, Principle Investigator, Abington Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00697606 History of Changes
Other Study ID Numbers:	Study #08-032
Study First Received:	June 12, 2008
Last Updated:	December 29, 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

ClinicalTrials.gov processed this record on July 24, 2017

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