Lymphedema Treatment for Blunt Facial Trauma
Status unconfirmed · Not applicable
Conditions studied: Post-traumatic Facial Edema
In brief
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.
Key facts
- Study ID
- NCT02977182
- Run by
- Our Lady of the Lake Hospital
- People needed
- 50
- Starts
- 2016-11-01
- Expected to finish
- 2018-11-01
- Last updated by the study team
- 2016-11-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult trauma patients 18 years of age or older
- Presence of facial trauma as determined by X-ray or computed tomography (CT)
- Presence of face/neck lymphedema characterized as at least Stage 1 on the MD Anderson Cancer Center's Head and Neck Lymphedema (HNL) rating scale
You may not qualify if…
- Less than 18 years of age
- Presence of injury to the carotid artery or jugular veins
- Presence of upper quadrant deep vein thrombosis
- Presence of known infection
- Unwilling or unable to consent (or unable to find an appropriate surrogate)
- Pregnant
- Expected death within 24 hours of enrollment, or desire by patient of family to pursue palliative rather than aggressive, supportive care
- Inability to speak English such that assessment of primary endpoints would not be feasible
- Prisoners
- Patients previously enrolled in another clinical trial
Where it is running
- Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States (enrolling)
Full record on ClinicalTrials.gov
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