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Interim analyses showed insufficient result. Termination for reasons of futility
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| Name | Class |
|---|---|
| Kimberly-Clark Corporation | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No use of integuseal | No Intervention | ||
| Use of Integuseal | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of Integuseal sealant | Procedure | Microbial sealant (integuseal) applied with a sponge applicator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative wound infections |
| Measure | Description | Time Frame |
|---|---|---|
| Costs of the use of Integuseal | ||
| Complications during hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel MPJ Reijnen, MD | Rijstate hospital Arnhem the Netherlands | Study Director |
| J. Klinkenbijl, MD | Study Director | |
| Sjoerd A de Beer, MD | Rijnstate Hospital Arnhem the Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Rijnstate | Arnhem | 6800 TA | Netherlands | |||
| Ziekenhuis Slingland |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
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| Doetinchem |
| Netherlands |
| Ziekenhuis Nij Smellinghe | Drachten | Netherlands |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |