Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
Myoma
About this trial
This is an interventional prevention trial for Myoma focused on measuring adhesions, gynecologic surgery, laparoscopy, laparotomy, polyethylene glycol, hydrogel, Adhesions following gynecologic surgery to remove myomas
Eligibility Criteria
Inclusion Criteria:
Preoperatively, subjects must have had:
- Been scheduled for myomectomy via laparotomy or laparoscopy.
- Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy.
- Been >=18 years of age.
- Provided voluntary written informed consent.
- Been willing to comply with all aspects of the treatment and evaluation schedule.
Intra-operatively, subjects must have had:
- Had at least one 2 cm incision length on posterior uterine surface, which may include the fundal surface.
Exclusion Criteria:
Preoperatively, subjects must not have had:
- Been pregnant.
- Had a pelvic malignancy.
- Had acute pelvic inflammatory disease.
- Had an immune compromised condition.
- Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study.
- Been given corticosteroids intra-operatively or during the course of the postoperative study follow up.
Intra-operatively, subjects must not have had:
- Had a pelvic malignancy.
- Had a pelvic or abdominal infection.
- Had acute pelvic inflammatory disease.
- Received any adhesion prevention adjuvants or barriers, or peritoneal instillates containing corticosteroids, NSAIDs, or Dextran.
Sites / Locations
- St. Joseph's Health Centre
- Klinik für Minimal Invasive Chirurgie
- Universitätsklinikum Giessen
- Univ. Clinics of Schleswig-Holstein
- Bethesda Krankenhaus Wupperta
- St. Elizabeth Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Other
1
2
Adhesion Prevention Gel Arm
Standard of Care Comparator Arm (standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure)