Seroma
Conditions
Keywords
seroma, doxycycline, post operative complications, sclerotherapy, fibrosis induction
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.
Interventions
DRUGDoxycycline
All participants will undergo incision and drainage with seroma washout and receive a single intraoperative injection of doxycycline (500mg) prior to fascial closure.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patient's will receive doxycycline upon development of post-operative seroma.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with recurrence of seroma | 6 months | Seroma recurrence is defined as re-accumulation of fluid at the operative site after prior resolution, confirmed by clinical exam or ultrasound. |
| Degree of fibrosis for remaining seroma on post-operative ultrasounds | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score Junior (KOOS JR) | 6 months postoperatively | 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. |
| Hip Disability and Osteoarthritis Outcome Score Junior (HOOS JR ) | 6 months postoperatively | Patient-reported questionnaire administered during routine postoperative clinic visits using the Hip Disability and Osteoarthritis Outcome Score Junior (HOOS JR) questionnaire, which evaluates joint-specific pain, stiffness, and functional ability following orthopedic surgery. Score range is from 0 to 100, with higher scores indicating better hip health and function. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 | 6 months postoperatively | The PROMIS Global Health-10 is a validated patient-reported outcome questionnaire assessing overall physical, mental, and social health. It includes items that generate two standardized summary scores: Global Physical Health (GPH) and Global Mental Health (GMH). Raw scores are converted to T-scores, each scaled with a mean of 50 and a standard deviation of 10, where higher scores indicate better overall health status. |
| UCLA Activity Score | 6 months postoperatively | The University of California, Los Angeles (UCLA) Activity Score is a validated patient-reported measure assessing physical activity level and functional mobility. Scores range from 1 to 10, where higher scores indicate higher activity levels (1 = completely inactive, dependent; 10 = regular participation in impact sports). The score reflects the patient's usual activity level during daily life and recreational activities. |
| EQ-5D Health-Related Quality of Life Score | 6 months postoperatively | Patient-reported questionnaire administered during routine postoperative clinic visits. Participants will complete the standard EQ-5D instrument, and responses will be converted to numerical index scores according to scoring guidelines. Scores range from values below 0 (indicating health states worse than death) to 1.0 (indicating full health), with higher scores reflecting better health-related quality of life. |
Countries
United States
Contacts
CONTACTRobert E Carrier, DO
PRINCIPAL_INVESTIGATORColin McNamara, MD
University of Miami
Outcome results
None listed