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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
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Seroma | Drug: doxycycline Other: No intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Doxycycline
Doxycyline, family of tetracycline antibiotics, used to scleroses the lymphatic vessels that may have transected during dissection.
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Drug: doxycycline
50 ml/mg |
Placebo Comparator: Normal Saline/Water
The standard care is wetting and suctioning fluids followed with suturing of the groin.
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Other: No intervention
Normal Saline/Water
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

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female candidates (>18 and <85 years of age) undergoing Cardiopulmonary By-Pass via Femoral/Groin access as part of their routine cardiothoracic scheduled procedure will be approached for their interest in participation in the study.
Exclusion Criteria:
- A history of allergic reaction to doxycycline (Adoxa, Doryx, Oracea, Vibramycin) or any classes of tetracyclines- demeclocycline (Declomycin), or minocycline (Dynacin, Minocin, Solodyn, Vectrin).
- Patients who are not undergoing Cardiopulmonary By-Pass through femoral access.
- Active infection in the groin region.
- Females who are pregnant or lactating and breast feeding.
- Who do not wish to participate in the study.

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 |
Responsible Party: | John P Nabagiez, MD, M.D., Northwell Health |
ClinicalTrials.gov Identifier: | NCT01188954 |
Other Study ID Numbers: |
Doxy 10-006 |
First Posted: | August 26, 2010 Key Record Dates |
Last Update Posted: | April 14, 2015 |
Last Verified: | April 2015 |
Seroma Doxycycline Cardiopulmonary By-Pass Femoral Artery/Vein Cannulation Prevent Seroma Formation |
Seroma Inflammation Pathologic Processes Doxycycline Anti-Bacterial Agents |
Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |