A Trial to Reduce Adhesions Following a Primary Cesarean Section
The primary objective of this study is to determine whether the use of Seprafilm reduces the incidence rate of adhesion formation following a primary C-section.
A secondary objective of the study will be to determine whether or not a correlation between the adhesion score and the difficulty or delay in delivery of the infant exists.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||A Randomized Controlled Trial to Reduce Adhesions Following a Primary Cesarean Section|
- Adhesion formation following a primary C-section with and without adhesion barrier [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Correlation between adhesions and difficulty or delay in delivery of the infant(s) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Treatment Group
Patients in this group will receive Seprafilm onto the uterine incision and the anterior midline of the uterus.
Seprafilm will be placed onto the uterine incision and the anterior midline of the uterus following the primary cesarean section
No Intervention: Control Group
This arm will be known as the control/no intervention group. This group will not receive Seprafilm or any other adhesion barrier method
A cesarean section or delivery (C-section/CD) is the surgical removal of an infant and placenta through the mother's abdominal and uterine wall. This procedure is performed by an obstetrician and is one of the most common types of surgical methods used today. According to the Centers for Disease Control and Prevention, the rate for this method of delivery has risen over the past decade. However, recent research has shown that patients who receive this surgical procedure become more susceptible to adhesions.
Adhesions are formations (bands) of scar tissue that occur immediately following most surgical procedures. Adhesions limit the mobility of tissues and organs near the incision site by causing them to stick together. This limited mobility can generate an increased rate of morbidity (occurrence of other diseases). Morbidities caused by adhesions include but are not limited to abdominal and/or pelvic pain, bowel obstruction (partial or complete blockage of the bowel), subfertility (difficulty getting pregnant) and infertility (inability to get pregnant).
A study conducted by Dierdre Lyell, MD reported that the incidence of adhesion formation following a primary CD ranges from 46-65%. Another study (Morales et al) reported that for women who had undergone a CD, the incidence rate of adhesions and severe adhesions was greater in women who had had repeat CDs compared with women who only had a primary CD. In addition, this study also states that the percentage of adhesion occurrence increases in women with each subsequent (following) CD.
Numerous methods have been implemented toward the preventions of adhesions. Currently, Seprafilm is an approved adhesion prevention method that is used in most surgical procedures. Seprafilm is a clear film that is composed of chemically modified sugars (some of which occur naturally in the human body). Unlike its counterpart Interceed, Seprafilm is unaffected by the presence of blood. After being placed, Seprafilm becomes a gel within 24-48 hours and then is slowly absorbed and excreted by the body over the course of 1-4 weeks.
Seprafilm Adhesion Barrier is FDA approved for use in patients undergoing abdominal or pelvis laparotomy as an adjunct intended to reduce the incidence, extent and severity of post-operative adhesions between the abdominal and between the uterus and surrounding structures.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01819467
|United States, North Carolina|
|New Hanover Regional Medical Center|
|Wilmington, North Carolina, United States, 28401|
|Principal Investigator:||Henry A Easley, MD||South East Area Health Education Center|