← Back to Search

Other

Active Treatment Group for Facial Swelling

N/A
Waitlist Available
Research Sponsored by Our Lady of the Lake Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks
Awards & highlights

Study Summary

Injuries to the face caused by traumatic events such as motor vehicle collisions, assault, and falls can result in facial trauma, which can result in swelling and disfiguration that impairs the important functions of the face, sometimes to a life threatening degree. These injures and the resultant swelling can also precipitate psychological and social consequences. Lymphedema is an abnormal amount of fluid that causes swelling, usually in the arms or legs. The most common presentation of lymphedema is in the upper extremities due to breast cancer treatment (Maclellean RA et al). As such, standards of care for management of lymphedema are primarily derived from the cancer research literature and involve the extremities (Moffatt CJ. 2003 QJM). The current gold standard treatment for patients with extremity lymphedema is complete decongestive therapy (CDT) (Zuther 2013). CDT is a multimodal therapy consisting of four components: manual lymph drainage, compression wrapping, exercise, and skin care (Zuther 2013).These same therapeutic techniques of CDT have been employed at Our Lady of the Lake Regional Medical Center (OLOLRMC) and adapted to treat patients with facial trauma with anecdotally good results primarily related to cosmesis. To the best of our knowledge, no clinical studies examining the effect of lymphedema treatment in the management of blunt facial trauma currently exist.. Beyond the consideration of cosmesis, we also seek to determine if this intervention improves clinical outcomes such as time to swallowing and reduced time utilizing mechanical ventilation. This study will prospectively evaluate the use of complete decongestive therapy to test the hypothesis that this intervention results in improved clinical outcomes in patients with blunt facial trauma.

Eligible Conditions
  • Facial Swelling

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite facial score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active Treatment GroupExperimental Treatment1 Intervention
The active treatment group will receive standard speech therapy treatments in addition to complete decongestive therapy from a certified Speech Language Pathologist (CCC-SLP) trained in CDT.
Group II: Control GroupActive Control1 Intervention
The control group will receive standard speech therapy treatments but not lymphedema treatment and will serve as the baseline for comparison for assessment of the effects of CDT.

Find a Location

Who is running the clinical trial?

Our Lady of the Lake HospitalLead Sponsor
12 Previous Clinical Trials
789 Total Patients Enrolled
Our Lady of the Lake Regional Medical CenterLead Sponsor
5 Previous Clinical Trials
419 Total Patients Enrolled
Danielle Tatum, PhDStudy DirectorOUR LADY OF THE LAKE RMC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Apr 2025