Doxycycline Versus Standard Care to Prevent Seroma Formation

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial of Doxycycline Versus Standard Care to Prevent Seroma Formation at Femoral Artery/Vein Cannulation Site After Cardiopulmonary By-Pass

Conditions
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Seroma

Intervention / Treatment
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* Drug: doxycycline
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seroma, Doxycycline, Cardiopulmonary By-Pass, Femoral Artery/Vein Cannulation, Prevent Seroma Formation