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SeromaPhase 2NCT07498010

Doxycycline Use in Post-Operative Seromas

A Phase 2 study testing Doxycycline in people with Seroma, run by University of Miami at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Seroma
What is being tested?
Doxycycline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
31 May 2026to 1 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Robert E Carrier, DO contact

413-478-8417

rec182@miami.edu

United States1 site, 1 recruiting

  • University of Miami

    Coral Gables, Florida, 33146

    Robert E Carrier, DO, 413-478-8417, rec182@miami.edu

    Colin McNamara, MD

    Recruiting

Other trials in United States

About this study

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

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
Being tested
Doxycycline
Keywords
seroma, doxycycline, post operative complications, sclerotherapy, fibrosis induction
Medical subject headings
Seroma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxycyclineDrug

    All participants will undergo incision and drainage with seroma washout and receive a single intraoperative injection of doxycycline (500mg) prior to fascial closure.

Study groups in NCT07498010
Study groupRoleWhat they receive
Intraoperative DoxycyclineExperimentalAll participants will receive a single injection intraoperative dose of doxycycline (500mg)
Receives: Drug: Doxycycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (5)

  1. 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.

    Measured: 6 months postoperatively

  2. Hip Disability and Osteoarthritis Outcome Score Junior (HOOS JR )

    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.

    Measured: 6 months postoperatively

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10

    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.

    Measured: 6 months postoperatively

  4. UCLA Activity Score

    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.

    Measured: 6 months postoperatively

  5. EQ-5D Health-Related Quality of Life Score

    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.

    Measured: 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start31 May 2026
  3. Primary completion10 May 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Patient's will receive doxycycline upon development of post-operative seroma.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498010
Sponsor's protocol ID
20251283
Status last verified
Apr 2026
First submitted
23 Mar 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxycycline in people with Seroma, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robert E Carrier, DO (413-478-8417, rec182@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with recurrence of seroma (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07498010.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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