Health TrialsbyHealthPanel

Doxycycline Use in Post-Operative Seromas

ConditionSeroma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

Seromas are collections of serous fluid that can develop following surgical procedures and may persist as fibrous-lined pseudocysts if not adequately treated. In orthopedic surgery, particularly after arthroplasty, seromas can impair wound healing, increase pain, and limit postoperative rehabilitation, potentially compromising patient recovery. Current treatment strategies including compression, percutaneous aspiration, and repeat surgical intervention have variable success, and aspiration carries the risk of introducing bacteria into an otherwise sterile fluid collection. Sclerotherapy has been proposed as an alternative strategy to induce fibrosis within the cavity and eliminate the potential space. Doxycycline, a tetracycline antibiotic commonly used for pleurodesis, has demonstrated sclerosing properties through mechanisms including mesothelial cell destruction, inhibition of fibrinolysis, and stimulation of fibroblast activity. While doxycycline sclerotherapy has shown success in treating conditions such as Morel-Lavallée lesions and has been described in isolated orthopedic case reports, its role in managing postoperative seromas after arthroplasty remains poorly studied. Further investigation is needed to determine whether doxycycline injection may serve as a safe and effective treatment to reduce persistent seromas and the need for additional interventions in orthopedic patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with seroma formation following orthopedic procedure

>18 years old

Willing and able to provide informed consent

Pre-operative imaging (US, CT) demonstrating seroma formation

Disqualifiers

Pregnancy or lactation

Age <18 years

Known allergy to tetracyclines

Significant hepatic or renal dysfunction (Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) >3× Upper Limit of Normal (ULN), Creatinine Clearance (CrCl <30 mL/min)

Trial design

Design model

Single group

Treatments tested in this trial

  • Doxycycline

    Drug

    All participants will undergo incision and drainage with seroma washout and receive a single intraoperative injection of doxycycline (500mg) prior to fascial closure.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Intraoperative DoxycyclineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with recurrence of seroma

Seroma recurrence is defined as re-accumulation of fluid at the operative site after prior resolution, confirmed by clinical exam or ultrasound.

Time frame
6 months
2

Degree of fibrosis for remaining seroma on post-operative ultrasounds

Participants will undergo postoperative ultrasound to assess the degree of residual seroma and fibrosis, including measurement of seroma dimensions, as evaluated by a trained radiologist.

Time frame
6 months

Secondary outcomes

1

Knee Injury and Osteoarthritis Outcome Score Junior (KOOS JR)

Patient-reported questionnaire administered during routine postoperative clinic visits using the Knee injury and Osteoarthritis Outcome Score Junior (KOOS JR). The score range is from 0 to 100, with higher scores indicating better knee health and function.

Time frame
6 months postoperatively
2

Hip Disability and Osteoarthritis Outcome Score Junior (HOOS JR )

Patient-reported questionnaire administered during routine postoperative clinic visits using the Hip Disability and Osteoarthritis Outcome Score Junior (HOOS JR) questionnaire, which evaluates joint-specific pain, stiffness, and functional ability following orthopedic surgery. Score range is from 0 to 100, with higher scores indicating better hip health and function.

Time frame
6 months postoperatively
3

Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10

The PROMIS Global Health-10 is a validated patient-reported outcome questionnaire assessing overall physical, mental, and social health. It includes items that generate two standardized summary scores: Global Physical Health (GPH) and Global Mental Health (GMH). Raw scores are converted to T-scores, each scaled with a mean of 50 and a standard deviation of 10, where higher scores indicate better overall health status.

Time frame
6 months postoperatively
4

UCLA Activity Score

The University of California, Los Angeles (UCLA) Activity Score is a validated patient-reported measure assessing physical activity level and functional mobility. Scores range from 1 to 10, where higher scores indicate higher activity levels (1 = completely inactive, dependent; 10 = regular participation in impact sports). The score reflects the patient's usual activity level during daily life and recreational activities.

Time frame
6 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
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