Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00512356 | Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions | PHASE2 | COMPLETED | 46 | — | — | Dec 1, 2000 | Apr 1, 2003 | Aug 4, 2017 | 7 | Denmark, Poland +1 |
| Arm | Type | Description |
|---|---|---|
| Investigational product group | EXPERIMENTAL | Anti-Adhesion Product was applied to the rectal stump and the incision line. Like in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. |
| Control group | NO_INTERVENTION | Only surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. No specific additional treatment was applied. |
| Name | Type | Description |
|---|---|---|
| Anti-Adhesion Product | BIOLOGICAL | Anti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components. |
Inclusion Criteria: * Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry * Male or female subjects \> 18 years of age * Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or m...