Doxycycline for Seromas
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether doxycycline, an antibiotic, can help treat seromas, which are fluid-filled pockets that sometimes form after orthopedic surgery. Seromas can cause pain and slow recovery, and current treatments often fall short. During surgery, participants will receive a doxycycline injection to determine if it reduces these fluid collections. This trial suits those who have developed a seroma after orthopedic surgery, confirmed by imaging tests like an ultrasound or CT scan. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
If you are currently taking isotretinoin, retinoids, anticoagulants, or immunosuppressants, you will need to stop these medications to participate in the trial.
Is there any evidence suggesting that doxycycline is likely to be safe for humans?
Research has shown that doxycycline is generally safe and well-tolerated for treating seromas. For instance, studies found that doxycycline effectively treats seromas around the hip without causing serious side effects. In some cases, it may even cure the condition. Other research indicates that doxycycline has been used safely for various conditions with a high success rate. While more studies are needed, current evidence suggests that doxycycline is a promising and safe option for managing seromas.12345
Why do researchers think this study treatment might be promising for seromas?
Unlike the standard treatments for seromas, which often involve drainage and compression therapies, doxycycline is being explored for its potential to prevent seromas from forming in the first place. Researchers are excited about this approach because doxycycline is administered as a single intraoperative injection, which could simplify the treatment process and reduce the need for repeated interventions. Additionally, doxycycline's anti-inflammatory properties may offer an innovative mechanism of action by directly influencing the biological processes involved in seroma formation.
What evidence suggests that doxycycline might be an effective treatment for seromas?
Research has shown that doxycycline can help treat seromas, which are pockets of fluid that can form after surgery. In some cases, it successfully treated long-lasting seromas, especially when other surgeries failed. Doxycycline works by causing scarring in the tissue, closing the space where fluid gathers. However, studies have shown mixed results. For instance, it was less effective than some surgical methods in preventing seromas. Still, it is considered a safe option for treating seromas around the hip. While doxycycline appears promising, more research is needed to confirm its effectiveness for seromas after bone surgeries. Participants in this trial will receive a single intraoperative dose of doxycycline to evaluate its effectiveness in treating seromas.12567
Who Is on the Research Team?
Colin McNamara, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for adults over 18 who have developed a seroma (fluid collection) after orthopedic surgery, confirmed by imaging. Participants must be able to give consent. People can't join if they are pregnant or breastfeeding, have severe liver or kidney problems, certain allergies, take specific medications, or have conditions affecting drug absorption.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intraoperative dose of doxycycline (500mg) to manage postoperative seromas
Follow-up
Participants are monitored for safety and effectiveness after treatment, including postoperative ultrasounds and patient-reported outcome measures
What Are the Treatments Tested in This Trial?
Interventions
- Doxycycline
Trial Overview
The study is testing whether injecting doxycycline into post-surgical seromas can help reduce fluid buildup and the need for further procedures in patients after orthopedic surgery. Doxycycline's sclerosing effect will be evaluated as an alternative treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will receive a single injection intraoperative dose of doxycycline (500mg)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Citations
Management of chronic abdominal wall seroma with ... - PMC
Our case report discusses the use of Doxycycline sclerotherapy in the successful resolution of a chronic abdominal wall seroma.
NCT07498010 | Doxycycline Use in Post-Operative Seromas
While doxycycline sclerotherapy has shown success in treating conditions such as Morel-Lavallée lesions and has been described in isolated ...
Unravelling the Efficacy of Internal Quilting Sutures vs ... - PMC
Doxycycline instillation was less effective than internal quilting sutures in preventing seroma formation. Internal quilting sutures are a safe effective ...
4.
eurjbreasthealth.com
eurjbreasthealth.com/articles/evaluation-of-topical-sclerosant-agents-for-minimization-of-postmastectomy-seroma-a-placebo-controlled-double-blind-randomized-trial/doi/ejbh.galenos.2023.2022-11-1Evaluation of Topical Sclerosant Agents for Minimization ...
These results suggest that sclerosant agents, specifically bleomycin and doxycycline, have no utility for prevention of post mastectomy seroma.
Unravelling the Efficacy of Internal Quilting Sutures vs ...
Doxycycline instillation was less effective than internal quilting sutures in preventing seroma formation. Internal quilting sutures are a ...
Seromadesis following total hip resurfacing by aspiration ...
Doxycycline is a safe and potentially curative treatment for seroma around the hip. References. ↵. Sood A,; Kotamarti VS,; Therattil PJ, et al . Sclerotherapy ...
A comprehensive review of seroma formation, prevention, ...
The seroma was successfully managed using doxycycline sclerotherapy combined with NPWT via the KCL-V.A.C. Ultrasystem. The procedure involved placing white foam ...
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