Lymphedema Treatment for Blunt Facial Trauma
Lymphedema Treatment for Blunt Facial Trauma
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.
Introduction The face is an anatomically complex structure, consisting of skin, muscles for
 both fine and gross motor functions, a complex bony structure, and vital sensory organs.
 These structures allow one to eat, breathe, see, hear, and speak. 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.1-3 Lymphedema is an abnormal
 amount of fluid that causes swelling, usually in the arms or legs. Though lymphedema can
 occur as a result of trauma, it is most commonly associated with side effects of certain
 cancer-related treatments such as radiation therapy and lymph node removal. The most common
 presentation of lymphedema is in the upper extremities due to breast cancer treatment.4 As
 such, standards of care for management of lymphedema are primarily derived from the cancer
 research literature and involve the extremities.5 The current gold standard treatment for
 patients with extremity lymphedema is complete decongestive therapy (CDT).6 CDT is a
 multimodal therapy consisting of four components: manual lymph drainage, compression
 wrapping, exercise, and skin care.6 Manual lymph drainage (MLD) is a delicate form of massage
 designed to improve tissue and cellular health by facilitating fluid removal from edematous
 areas. Compression wrapping utilizes compression garments or short stretch compression
 bandages and is primarily used in the acute (or intensive) phase of CDT as a means to
 reinstate sufficient resistance to skin tissues whose elastic fibers are damaged by
 lymphedema. Exercise, especially when combined with compression, improves removal of fluid
 from the affected area. Finally, skin care treatments keep skin clean and moisturized to
 reduce infections that can occur with lymphedema.6 These same therapeutic techniques of CDT
 have been employed at Our Lady of the Lake Regional Medical Center (OLOLRMC) and adapted to
 treat facial edema in patients with facial trauma with anecdotally good results in terms of
 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.

 Specific Aims Specific Aim I: To determine whether complete decongestive therapy can
 significantly reduce facial lymphedema as measured by a previously established facial
 composite scoring protocol.

 Specific Aim II: To determine whether complete decongestive therapy can improve clinical
 outcomes for patients with facial trauma Study Objective and Endpoints Study Objective The
 primary objective of this study is to determine the effect(s), if any, of complete
 decongestive therapy in the management of facial trauma.

 Primary Endpoint The primary endpoint will be the composite facial score measured on the day
 of discharge from the Trauma Neuro Critical Care (TNCC) intensive care unit (ICU) at OLOLRMC.
 This measurement is based on the Head & Neck Lymphedema (HNL) program at MD Anderson Cancer
 Center (MDACC) whose standard evaluation protocol includes specific point-to-point
 measurements of the face (Smith & Lewin 2010; Smith and Lewin 2014). A series of key facial
 measurements are totaled to provide a "composite facial score". Based on the clinical
 experience at MDACC with more than 150 patients, their HNL program has developed criteria to
 define clinically detectable improvements in external HNL. Those criteria are a drop in
 lymphedema stage or a minimum threshold of 2% reduction in the composite measurement equating
 to at least a 2-cm change in absolute values (Smith & Lewin 2014).

 Secondary endpoints

 Because the facial and neck composite scores only provide evaluation of the extent of edema,
 we also seek to assess patient outcomes with regards to the following:

 1. Stage of lymphedema as defined by the MDACC HNL edema rating scale

 2. Number of mechanical ventilation days

 3. Narcotic pain medicine utilization

 4. Steroid utilization

 5. Pain scale scores as determined by the Visual Analog Scale or the adult non-verbal pain
 score

 6. Time to swallowing

 7. ICU length of stay (ICULOS)

 8. Hospital length of stay (LOS)
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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