Doxycycline Versus Standard Care to Prevent Seroma Formation

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

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 Overview

• Status: Withdrawn
• Conditions: Seroma
• Intervention / Treatment: Drug: doxycycline; Other: No intervention

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Kourosh T Asgarian, DO, Staten Island University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 10, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Doxycycline; Seroma; Cardiopulmonary By-Pass; Femoral Artery/Vein Cannulation; Prevent Seroma Formation
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: Doxy 10-006