Doxycycline Versus Standard Care to Prevent Seroma Formation
Primary Purpose
Seroma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
doxycycline
No intervention
Sponsored by
About this trial
This is an interventional prevention trial for Seroma focused on measuring Seroma, Doxycycline, Cardiopulmonary By-Pass, Femoral Artery/Vein Cannulation, Prevent Seroma Formation
Eligibility 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.
Sites / Locations
- Staten Island University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Doxycycline
Normal Saline/Water
Arm Description
Doxycyline, family of tetracycline antibiotics, used to scleroses the lymphatic vessels that may have transected during dissection.
The standard care is wetting and suctioning fluids followed with suturing of the groin.
Outcomes
Primary Outcome Measures
evaluate the efficacy of doxycycline in the prevention of the complication of seroma post-cannulation
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01188954
Brief Title
Doxycycline Versus Standard Care to Prevent Seroma Formation
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 Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The recruitment process was slower than expected.
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma
Keywords
Seroma, Doxycycline, Cardiopulmonary By-Pass, Femoral Artery/Vein Cannulation, Prevent Seroma Formation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doxycycline
Arm Type
Active Comparator
Arm Description
Doxycyline, family of tetracycline antibiotics, used to scleroses the lymphatic vessels that may have transected during dissection.
Arm Title
Normal Saline/Water
Arm Type
Placebo Comparator
Arm Description
The standard care is wetting and suctioning fluids followed with suturing of the groin.
Intervention Type
Drug
Intervention Name(s)
doxycycline
Intervention Description
50 ml/mg
Intervention Type
Other
Intervention Name(s)
No intervention
Other Intervention Name(s)
Normal Saline, Sterile Water
Intervention Description
Normal Saline/Water
Primary Outcome Measure Information:
Title
evaluate the efficacy of doxycycline in the prevention of the complication of seroma post-cannulation
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Identification of predictors of response and complication
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kourosh T Asgarian, DO
Organizational Affiliation
Staten Island University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11200357
Citation
Caliendo MV, Lee DE, Queiroz R, Waldman DL. Sclerotherapy with use of doxycycline after percutaneous drainage of postoperative lymphoceles. J Vasc Interv Radiol. 2001 Jan;12(1):73-7. doi: 10.1016/s1051-0443(07)61407-9.
Results Reference
background
PubMed Identifier
15564260
Citation
Swan MC, Furniss D, Cassell OC. Surgical management of metastatic inguinal lymphadenopathy. BMJ. 2004 Nov 27;329(7477):1272-6. doi: 10.1136/bmj.329.7477.1272. No abstract available.
Results Reference
background
PubMed Identifier
8205870
Citation
Heffner JE, Standerfer RJ, Torstveit J, Unruh L. Clinical efficacy of doxycycline for pleurodesis. Chest. 1994 Jun;105(6):1743-7. doi: 10.1378/chest.105.6.1743.
Results Reference
background
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Doxycycline Versus Standard Care to Prevent Seroma Formation
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