Doxycycline Versus Standard Care to Prevent Seroma Formation
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|ClinicalTrials.gov Identifier: NCT01188954|
Recruitment Status : Withdrawn (The recruitment process was slower than expected.)
First Posted : August 26, 2010
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Seroma||Drug: doxycycline Other: No intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial of Doxycycline Versus Standard Care to Prevent Seroma Formation at Femoral Artery/Vein Cannulation Site After Cardiopulmonary By-Pass|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Active Comparator: Doxycycline
Doxycyline, family of tetracycline antibiotics, used to scleroses the lymphatic vessels that may have transected during dissection.
Placebo Comparator: Normal Saline/Water
The standard care is wetting and suctioning fluids followed with suturing of the groin.
Other: No intervention
Other Name: Normal Saline, Sterile Water
- evaluate the efficacy of doxycycline in the prevention of the complication of seroma post-cannulation [ Time Frame: 1 year ]The primary aim of this study is to evaluate the efficacy of doxycycline in the prevention of the complication of seroma post-cannulation for cardiopulmonary bypass via femoral access, when compared to standard care.
- Identification of predictors of response and complication [ Time Frame: 1 year ]The secondary aims include identification of predictors of response and complication, and success rates, as well as, assessment of clinical outcome and Health-Well Being
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188954
|United States, New York|
|Staten Island University Hospital|
|Staten Island, New York, United States, 10305|
|Principal Investigator:||Kourosh T Asgarian, DO||Staten Island University Hospital|