Lymphedema Treatment for Blunt Facial Trauma

NCT02977182 | Unknown

• 1 other identifier: 9521
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Facial Edema

Outcome Measures

Primary Outcomes (1)

• Composite facial score

  This measurement is based on the Head \& Neck Lymphedema program at MD Anderson Cancer Center whose standard evaluation protocol includes specific point-to-point measurements of the face which are totaled to provide a composite facial score.

  Up to 2 weeks

Study Arms (2)

Control Group

NO 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.

Active Treatment Group

EXPERIMENTAL

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.

Other: Complete Decongestive Therapy (CDT)

Interventions

Complete Decongestive Therapy (CDT) OTHER

CDT is a multimodal therapy consisting of four components: manual lymph drainage, compression wrapping, exercise, and skin care

Active Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead

Study Sites (1)

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 12856251 BACKGROUND

• 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.

  PMID: 12794453 BACKGROUND

• 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.

  PMID: 24691335 BACKGROUND

• 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.

  PMID: 17297333 BACKGROUND

• 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.

  PMID: 14500859 BACKGROUND

• 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.

  PMID: 21868611 BACKGROUND

Study Officials

• Danielle Tatum, PhD

  OUR LADY OF THE LAKE RMC

  STUDY DIRECTOR

Central Study Contacts

Danielle Tatum, PhD

CONTACT

2257656649; Danielle.Tatum@ololrmc.com

Jeffrey Gruner, MD, FACS

CONTACT

2257656893; Jeffrey.Gruner@ololrmc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Research Director

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 30, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 30, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)