Doxycycline Use in Post-Operative Seromas

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Seroma
• Intervention / Treatment: Drug: Doxycycline

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Robert E Carrier, DO; Phone Number: 413-478-8417; Email: rec182@miami.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami
      • Principal Investigator: Colin McNamara, MD
      • Contact: Robert E Carrier, DO; Phone Number: 413-478-8417; Email: rec182@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative Doxycycline; All participants will receive a single injection intraoperative dose of doxycycline (500mg)	Drug: Doxycycline; All participants will undergo incision and drainage with seroma washout and receive a single intraoperative injection of doxycycline (500mg) prior to fascial closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months postoperatively
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.	6 months postoperatively
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.	6 months postoperatively
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.	6 months postoperatively
EQ-5D Health-Related Quality of Life Score	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.	6 months postoperatively

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Colin McNamara, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sclerotherapy; doxycycline; seroma; post operative complications; fibrosis induction
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Pathological Conditions, Signs and Symptoms; Seroma; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Naphthacenes; Tetracyclines; Doxycycline
• Other Study ID Numbers: 20251283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No