Recruiting

Lymphedema Treatment

Sponsor:

Our Lady of the Lake Hospital

Code:

NCT02977182

Conditions

Post-traumatic Facial Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Complete Decongestive Therapy (CDT)

Study Details

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

Study ID

NCT02977182

Start date

Nov, 2016

Status verified date

Nov, 2016

Completion date

Nov, 2018

Anticipated

Primary completion date

Nov, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Group

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.

experimental: Active Treatment Group

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.

Interventions

Complete Decongestive Therapy (CDT)

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

Primary outcome measure

  • Composite facial score [ Time Frame: Up to 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

Our Lady of the Lake Regional Medical Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

More Information

Sponsor

Our Lady of the Lake Hospital

Last update posted

Nov 30, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Our Lady of the Lake Hospital on 2016-11-30.