Seprafilm® for Prevention of Adhesions at Repeat Cesarean
| Status: | Terminated |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 10/14/2017 |
| Start Date: | July 2008 |
| End Date: | June 2011 |
Randomized Double-Blind Controlled Study to Determine if Seprafilm® Reduces Adhesions After Primary Cesarean Section
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.
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.
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.
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.
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.
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Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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