Clinical trial NCT02977182: Lymphedema Treatment for Blunt Facial Trauma
Official title: The Effect of Lymphedema Treatment for the Management of Blunt Facial Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-traumatic Facial Edema
Lead sponsor: Our Lady of the Lake Hospital
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Composite facial score
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
Study officials:
affiliation: OUR LADY OF THE LAKE RMC
name: Danielle Tatum, PhD
role: STUDY_DIRECTOR
References:
citation: Glynn SM, Asarnow JR, Asarnow R, Shetty V, Elliot-Brown K, Black E, Belin TR. The development of acute post-traumatic stress disorder after orofacial injury: a prospective study in a large urban hospital. J Oral Maxillofac Surg. 2003 Jul;61(7):785-92. doi: 10.1016/s0278-2391(03)00239-8.
citation: Rankin M, Borah GL. Perceived functional impact of abnormal facial appearance. Plast Reconstr Surg. 2003 Jun;111(7):2140-6; discussion 2147-8. doi: 10.1097/01.PRS.0000060105.63335.0C.
citation: Maclellan RA, Couto RA, Sullivan JE, Grant FD, Slavin SA, Greene AK. Management of Primary and Secondary Lymphedema: Analysis of 225 Referrals to a Center. Ann Plast Surg. 2015 Aug;75(2):197-200. doi: 10.1097/SAP.0000000000000022.
citation: Glynn SM, Shetty V, Elliot-Brown K, Leathers R, Belin TR, Wang J. Chronic posttraumatic stress disorder after facial injury: a 1-year prospective cohort study. J Trauma. 2007 Feb;62(2):410-8; discussion 418. doi: 10.1097/01.ta.0000231556.05899.b0.
citation: Moffatt CJ, Franks PJ, Doherty DC, Williams AF, Badger C, Jeffs E, Bosanquet N, Mortimer PS. Lymphoedema: an underestimated health problem. QJM. 2003 Oct;96(10):731-8. doi: 10.1093/qjmed/hcg126.
citation: Cohen MD. Complete decongestive physical therapy in a patient with secondary lymphedema due to orthopedic trauma and surgery of the lower extremity. Phys Ther. 2011 Nov;91(11):1618-26. doi: 10.2522/ptj.20100101. Epub 2011 Aug 25.