Lymphedema Treatment for 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