Doxycycline Use in Post-Operative Seromas

NCT07498010 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 20251283
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Seroma

Keywords

seroma; doxycycline; post operative complications; sclerotherapy; fibrosis induction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Knee Injury and Osteoarthritis Outcome Score Junior (KOOS JR)

  6 months postoperatively

• Hip Disability and Osteoarthritis Outcome Score Junior (HOOS JR )

  6 months postoperatively

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

  6 months postoperatively

• UCLA Activity Score

  6 months postoperatively

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

  6 months postoperatively

Study Arms (1)

Intraoperative Doxycycline

EXPERIMENTAL

All participants will receive a single injection intraoperative dose of doxycycline (500mg)

Drug: Doxycycline

Interventions

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.

Intraoperative Doxycycline

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Seroma

Interventions

Doxycycline

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

Study Officials

• Colin McNamara, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert E Carrier, DO

CONTACT

413-478-8417; rec182@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Model Details: Patient's will receive doxycycline upon development of post-operative seroma.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)