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Doxycycline Use in Post-Operative Seromas

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University of Miami

Status and phase

Begins enrollment this month
Phase 2

Conditions

Seroma

Treatments

Drug: Doxycycline

Study type

Interventional

Funder types

Other

Identifiers

NCT07498010
20251283

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Intraoperative Doxycycline
Experimental group
Description:
All participants will receive a single injection intraoperative dose of doxycycline (500mg)
Treatment:
Drug: Doxycycline

Trial contacts and locations

1

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Central trial contact

Robert E Carrier, DO

Data sourced from clinicaltrials.gov

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