Doxycycline Versus Standard Care to Prevent Seroma Formation

Seroma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01188954
• Other study ID #: Doxy 10-006
• Status: Withdrawn
• Phase: N/A
• First received: June 22, 2010
• Last updated: April 10, 2015
• Start date: January 2010
• Est. completion date: November 2012

Study information

• Verified date: April 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Seroma

Intervention

Drug:
• doxycycline
50 ml/mg

Other:
• No intervention
Normal Saline/Water

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Heffner JE, Standerfer RJ, Torstveit J, Unruh L. Clinical efficacy of doxycycline for pleurodesis. Chest. 1994 Jun;105(6):1743-7. — View Citation

Swan MC, Furniss D, Cassell OC. Surgical management of metastatic inguinal lymphadenopathy. BMJ. 2004 Nov 27;329(7477):1272-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No