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NCT Number: NCT07498010

Doxycycline Use in Post-Operative Seromas

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.

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Key information

Conditions

Seroma Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Location status: Recruiting

Location contact

Colin McNamara, MD

PRINCIPAL_INVESTIGATOR

Robert E Carrier, DO

CONTACT

[email protected]

413-478-8417

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • History of photosensitivity or photodermatosis
  • Concurrent isotretinoin or retinoid therapy
  • Current use of anticoagulants or immunosuppressants
  • Active GI ulceration or esophageal disease
  • Any condition likely to impair adherence or drug absorption (e.g., malabsorption syndromes)

Treatment and study plan

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.

Primary outcomes

  1. Number of participants with recurrence of seroma

    Time frame: 6 months

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

  2. Degree of fibrosis for remaining seroma on post-operative ultrasounds

    Time frame: 6 months

    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.

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score Junior (KOOS JR)

    Time frame: 6 months postoperatively

    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.

  2. Hip Disability and Osteoarthritis Outcome Score Junior (HOOS JR )

    Time frame: 6 months postoperatively

    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.

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

    Time frame: 6 months postoperatively

    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.

  4. UCLA Activity Score

    Time frame: 6 months postoperatively

    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.

  5. EQ-5D Health-Related Quality of Life Score

    Time frame: 6 months postoperatively

    Patient-reported questionnaire administered during routine postoperative clinic visits. Participants will complete the standard EQ-5D instrument, and responses will be converted to numerical index scores according to scoring guidelines. Scores range from values below 0 (indicating health states worse than death) to 1.0 (indicating full health), with higher scores reflecting better health-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert E Carrier, DO

CONTACT

[email protected]

413-478-8417

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

The Role of Doxycycline in the Management of Postoperative Seromas: A Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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