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Recruiting NCT07498010

Doxycycline Use in Post-Operative Seromas

Phase II Interventional Seroma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doxycycline.
Who it may be relevant to
Registry conditions: Seroma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Number of participants with recurrence of seroma [Time frame: 6 months]
  • Degree of fibrosis for remaining seroma on post-operative ultrasounds [Time frame: 6 months]
Secondary outcome measures (5)
  • Knee Injury and Osteoarthritis Outcome Score Junior (KOOS JR) [Time frame: 6 months postoperatively]
  • Hip Disability and Osteoarthritis Outcome Score Junior (HOOS JR ) [Time frame: 6 months postoperatively]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 [Time frame: 6 months postoperatively]
  • UCLA Activity Score [Time frame: 6 months postoperatively]
  • EQ-5D Health-Related Quality of Life Score [Time frame: 6 months postoperatively]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Miami — Coral Gables

Identifiers

NCT: NCT07498010 · 20251283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗