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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00940979
Other study ID # LTC 625-230609
Secondary ID
Status Terminated
Phase N/A
First received July 16, 2009
Last updated January 10, 2014
Start date January 2010
Est. completion date May 2011

Study information

Verified date January 2014
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Intervention

Procedure:
Application of Integuseal sealant
Microbial sealant (integuseal) applied with a sponge applicator

Locations

Country Name City State
Netherlands Ziekenhuis Rijnstate Arnhem
Netherlands Ziekenhuis Slingland Doetinchem
Netherlands Ziekenhuis Nij Smellinghe Drachten

Sponsors (2)

Lead Sponsor Collaborator
Rijnstate Hospital Kimberly-Clark Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative wound infections
Secondary Costs of the use of Integuseal
Secondary Complications during hospital stay
See also
  Status Clinical Trial Phase
Completed NCT00132912 - Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573) Phase 2