Doxycycline Use in Post-Operative Seromas

Phase 2Not Yet RecruitingNCT07498010

University of Miami10 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Seroma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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.