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Trial record 73 of 215 for:    TETRACYCLINE

Doxycycline Versus Standard Care to Prevent Seroma Formation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (The recruitment process was slower than expected.)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

Tracking Information
First Submitted Date  ICMJE June 22, 2010
First Posted Date  ICMJE August 26, 2010
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01188954 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Doxycycline Versus Standard Care to Prevent Seroma Formation
Official Title  ICMJE Randomized Clinical Trial of Doxycycline Versus Standard Care to Prevent Seroma Formation at Femoral Artery/Vein Cannulation Site After Cardiopulmonary By-Pass
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Seroma
Intervention  ICMJE
  • Drug: doxycycline
    50 ml/mg
  • Other: No intervention
    Normal Saline/Water
    Other Name: Normal Saline, Sterile Water
Study Arms  ICMJE
  • Active Comparator: Doxycycline
    Doxycyline, family of tetracycline antibiotics, used to scleroses the lymphatic vessels that may have transected during dissection.
    Intervention: Drug: doxycycline
  • Placebo Comparator: Normal Saline/Water
    The standard care is wetting and suctioning fluids followed with suturing of the groin.
    Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 10, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2010)
303
Actual Study Completion Date  ICMJE November 2012
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01188954
Other Study ID Numbers  ICMJE Doxy 10-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John P Nabagiez, MD, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kourosh T Asgarian, DO Staten Island University Hospital
PRS Account Northwell Health
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP