Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities
Not Applicable
Terminated
- Conditions
- Arterial Obstructive Diseases
- Interventions
- Procedure: Application of Integuseal sealant
- Registration Number
- NCT00940979
- Lead Sponsor
- Rijnstate Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
- planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft
Exclusion Criteria
- secondary procedures and suprainguinal procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Use of Integuseal Application of Integuseal sealant Application of a layer of Integuseal (Cyanoacrylate) from a ready to use applicator preoperative before incision Polymerisation immobilise the bacteria that survived the conventional skin preparation This way there will be les contamination of the wound.
- Primary Outcome Measures
Name Time Method Postoperative wound infections
- Secondary Outcome Measures
Name Time Method Costs of the use of Integuseal Complications during hospital stay
Trial Locations
- Locations (3)
Ziekenhuis Nij Smellinghe
🇳🇱Drachten, Netherlands
Ziekenhuis Rijnstate
🇳🇱Arnhem, Netherlands
Ziekenhuis Slingland
🇳🇱Doetinchem, Netherlands