Doxycycline Versus Standard Care to Prevent Seroma Formation
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.
|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|
- 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.
- 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
|Study Start Date:||January 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Doxycycline
Doxycyline, family of tetracycline antibiotics, used to scleroses the lymphatic vessels that may have transected during dissection.
Placebo Comparator: Normal Saline/Water
The standard care is wetting and suctioning fluids followed with suturing of the groin.
Other: No intervention
Other Name: Normal Saline, Sterile Water
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188954
|United States, New York|
|Staten Island University Hospital|
|Staten Island, New York, United States, 10305|
|Principal Investigator:||Kourosh T Asgarian, DO||Staten Island University Hospital|