Doxycycline Versus Standard Care to Prevent Seroma Formation

NCT01188954 | Withdrawn DMC

• 1 other identifier: Doxy 10-006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Seroma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identification of predictors of response and complication

  1 year

Study Arms (2)

Doxycycline

ACTIVE COMPARATOR

Doxycyline, family of tetracycline antibiotics, used to scleroses the lymphatic vessels that may have transected during dissection.

Drug: doxycycline

Normal Saline/Water

PLACEBO COMPARATOR

The standard care is wetting and suctioning fluids followed with suturing of the groin.

Other: No intervention

Interventions

doxycycline DRUG

50 ml/mg

Doxycycline

No intervention OTHER

Normal Saline/Water

Also known as: Normal Saline, Sterile Water

Normal Saline/Water

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Related 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. doi: 10.1016/s1051-0443(07)61407-9.

  PMID: 11200357 BACKGROUND

• 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.

  PMID: 15564260 BACKGROUND

• 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.

  PMID: 8205870 BACKGROUND

MeSH Terms

Conditions

Seroma

Interventions

Doxycycline; Saline Solution

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kourosh T Asgarian, DO

  Staten Island University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: August 26, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (1)