Doxycycline Versus Standard Care to Prevent Seroma Formation

This study has been terminated.
(The recruitment process was slower than expected.)
Sponsor:
Information provided by (Responsible Party):
John P Nabagiez, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01188954
First received: June 22, 2010
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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 Intervention
Seroma
Drug: doxycycline
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • evaluate the efficacy of doxycycline in the prevention of the complication of seroma post-cannulation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Identification of predictors of response and complication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Enrollment: 70
Study Start Date: January 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188954

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Kourosh T Asgarian, DO Staten Island University Hospital
  More Information

Publications:
Responsible Party: John P Nabagiez, MD, M.D., North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01188954     History of Changes
Other Study ID Numbers: Doxy 10-006
Study First Received: June 22, 2010
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Seroma
Doxycycline
Cardiopulmonary By-Pass
Femoral Artery/Vein Cannulation
Prevent Seroma Formation

Additional relevant MeSH terms:
Seroma
Inflammation
Pathologic Processes
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 28, 2014