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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Recruitment Status : Withdrawn (The recruitment process was slower than expected.)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
Sponsor:
Information provided by (Responsible Party):
John P Nabagiez, MD, Northwell Health

Brief Summary:
A seroma is a collection of fluid other than pus or blood which forms through the division of numerous lymphatic channels, which normally drain the interstitial space under the skin. These channels become disrupted during surgical procedure and lead to seroma formation. This collection of fluid causes pressure in the local area, patient discomfort, and provides unfortunately an excellent culture medium for bacteria. Seroma development has been previously described in femoral vessel groin cannulation dissections after surgery. Conventional therapy is limited to draining the fluid, sometimes more than once, until there is full resolution of the seroma. If fluid collection recurs at the surgical site, sclerosant therapy with agents such as doxycycline. Doxycycline has been found to be a cost effective agent used as a sclerosant, which belongs to tetracycline class of antibiotics. The investigators hypothesize that prophylactic use of doxycycline at the site of femoral cannulation will prevent or minimize the area of seroma formation as compared to standard care of patients. The aim is driven towards limiting patient discomfort and visits to the clinic and to improve clinical care.

Condition or disease Intervention/treatment Phase
Seroma Drug: doxycycline Other: No intervention Not Applicable

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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

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Arm Intervention/treatment
Active Comparator: Doxycycline
Doxycyline, family of tetracycline antibiotics, used to scleroses the lymphatic vessels that may have transected during dissection.
Drug: doxycycline
50 ml/mg

Placebo Comparator: Normal Saline/Water
The standard care is wetting and suctioning fluids followed with suturing of the groin.
Other: No intervention
Normal Saline/Water
Other Name: Normal Saline, Sterile Water




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Kourosh T Asgarian, DO Staten Island University Hospital

Publications:
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Responsible Party: John P Nabagiez, MD, M.D., Northwell Health
ClinicalTrials.gov Identifier: NCT01188954     History of Changes
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
Keywords provided by John P Nabagiez, MD, Northwell Health:
Seroma
Doxycycline
Cardiopulmonary By-Pass
Femoral Artery/Vein Cannulation
Prevent Seroma Formation
Additional relevant MeSH terms:
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Seroma
Inflammation
Pathologic Processes
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents