Doxycycline Versus Standard Care to Prevent Seroma Formation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains

NCT01608854

Surgical Wound Infection Spinal Deformity Spinal Degeneration

COMPLETED

Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease

NCT02385695

Lumbar Spine Disc Degeneration

UNKNOWN

Surgical Versus Nonsurgical Treatment for Spinal Stenosis

NCT00022776

Spinal Stenosis

COMPLETED PHASE3

Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.

NCT05146583

Lumbar Disc Disease

UNKNOWN

Instability in the Lumbar Spine of Patients With Age Related Changes and Narrowing of the Spinal Canal (Spinal Stenosis)

NCT04406987

Degenerative Lumbar Spinal Stenosis Degenerative Spondylolisthesis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seroma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Doxycycline

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

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

50 ml/mg

Normal Saline/Water

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

Group Type PLACEBO_COMPARATOR

No intervention

Intervention Type OTHER

Normal Saline/Water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

doxycycline

50 ml/mg

Intervention Type DRUG

No intervention

Normal Saline/Water

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Normal Saline, Sterile Water

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No