Clinical trial NCT01188954: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Seroma
Keywords: Seroma
Doxycycline
Cardiopulmonary By-Pass
Femoral Artery/Vein Cannulation
Prevent Seroma Formation
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: evaluate the efficacy of doxycycline in the prevention of the complication of seroma post-cannulation
timeFrame: 1 year
Secondary outcomes:
measure: Identification of predictors of response and complication
timeFrame: 1 year
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Kourosh T Asgarian, DO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.