Recruiting
Phase 2

Doxycycline Sclerotherapy

Sponsor:

University of Miami

Code:

NCT07498010

Conditions

Seroma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doxycycline

Study Details

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

Study ID

NCT07498010

Start date

May 31, 2026

Status verified date

Apr, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

May 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intraoperative Doxycycline

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

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Robert E Carrier, DO

413-478-8417rec182@miami.edu

Locations

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Robert E Carrier, DO

413-478-8417rec182@miami.edu

Principal Investigator:

Colin McNamara, MD

More Information

Sponsor

University of Miami

Last update posted

Jul 9, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-09.