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临床试验/NCT07498010
NCT07498010招募中2 期

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

University of Miami1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年5月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
10
试验地点
1
主要终点
Number of participants with recurrence of seroma

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Intraoperative Doxycycline

Experimental

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

干预措施: Doxycycline (Drug)

结局指标

主要结局

Number of participants with recurrence of seroma

时间窗: 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

时间窗: 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.

次要结局

  • Knee Injury and Osteoarthritis Outcome Score Junior (KOOS JR)(6 months postoperatively)
  • Hip Disability and Osteoarthritis Outcome Score Junior (HOOS JR )(6 months postoperatively)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10(6 months postoperatively)
  • UCLA Activity Score(6 months postoperatively)
  • EQ-5D Health-Related Quality of Life Score(6 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Colin A. McNamara

Assistant Professor of Clinical Medicine

University of Miami

研究点 (1)

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