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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Identification of predictors of response and complication [ Time Frame: 1 year ]
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