Trials / Completed
CompletedNCT00597662
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare adhesion prophylaxis with polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety, side effects and usability in addition to gaining early evidence of the effectiveness of polylactide-caprolactone-trimethylenecarbonate copolymer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | polylactide-caprolactone-trimethylenecarbonate copolymer | Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum |
| DEVICE | Icodextrin 4% | 1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2008-04-01
- First posted
- 2008-01-18
- Last updated
- 2008-06-10
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00597662. Inclusion in this directory is not an endorsement.