Doxycycline Versus Standard Care to Prevent Seroma Formation

• ClinicalTrials.gov Identifier: NCT01188954
• Recruitment Status: Withdrawn
• First Posted: August 26, 2010
• Last Update Posted: April 14, 2015
• Sponsor: Northwell Health
• Information provided by (Responsible Party): John P Nabagiez, MD, Northwell Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Seroma	Drug: doxycycline; Other: No intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: January 2010
• Estimated Primary Completion Date: November 2012
• Actual Study Completion Date: November 2012

Arms and Interventions

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 Name: Normal Saline, Sterile Water

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

Staten Island University Hospital

Staten Island, New York, United States, 10305

Sponsors and Collaborators

Northwell Health

Investigators

• Principal Investigator: Kourosh T Asgarian, DO; Staten Island University Hospital

More Information

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.

• Responsible Party: John P Nabagiez, MD, M.D., Northwell Health
• ClinicalTrials.gov Identifier: NCT01188954
• Other Study ID Numbers: Doxy 10-006
• First Posted: August 26, 2010
• Last Update Posted: April 14, 2015
• Last Verified: April 2015

Keywords provided by John P Nabagiez, MD, Northwell Health:

Seroma; Doxycycline; Cardiopulmonary By-Pass; Femoral Artery/Vein Cannulation; Prevent Seroma Formation

Additional relevant MeSH terms:

Seroma; Inflammation; Pathologic Processes; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents