Clinical trial · Interventional
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery
NCT00562471CI-TRIAL-00000994completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myoma | Myoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adhibit Adhesion Prevention Gel | Other | — | UNRESOLVED |
| Standard of Care Comparator | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Adhesion Prevention Gel Arm
- interventionNames
- Other: Adhibit Adhesion Prevention Gel
- type
- OTHER
- label
- 2
- description
- 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)
- interventionNames
- Other: Standard of Care Comparator
Primary outcomes (1)
- measure
- modified American Fertility Society (mAFS) score at the posterior uterus
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMettler L, Hucke J, Bojahr B, Tinneberg HR, Leyland N, Avelar R. A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy. Hum Reprod. 2008 May;23(5):1093-100. doi: 10.1093/humrep/den080. Epub 2008 Mar 17. PMID 18346996