Arterial Obstructive Diseases Clinical Trial
— ITTOfficial title:
Prospective Randomised Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities
The purpose of this study is to prove a reduction of postoperative wound infections after direct preoperative use of a microbial sealant in the form of Integuseal for vascular procedures on lower extremities.
Status | Terminated |
Enrollment | 450 |
Est. completion date | May 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft Exclusion Criteria: - secondary procedures and suprainguinal procedures |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Netherlands | Ziekenhuis Rijnstate | Arnhem | |
Netherlands | Ziekenhuis Slingland | Doetinchem | |
Netherlands | Ziekenhuis Nij Smellinghe | Drachten |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital | Kimberly-Clark Corporation |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative wound infections | |||
Secondary | Costs of the use of Integuseal | |||
Secondary | Complications during hospital stay |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00132912 -
Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)
|
Phase 2 |