Clinical Trial: Doxycycline Versus Standard Care to Prevent Seroma Formation

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Northwell Health

Current Primary Outcome: 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: Same as current

Current Secondary Outcome: 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: Same as current

Information By: Northwell Health

Dates:
Date Received: June 22, 2010
Date Started: January 2010
Date Completion:
Last Updated: April 10, 2015
Last Verified: April 2015