Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours
研究概览
简要总结
Cellulitis is the medical term for an infection of the skin, with symptoms including redness, swelling, warmth, and pain. This group of symptoms is called inflammation, and is caused by the body's immune system responding to the infection. Standard care for cellulitis is using antibiotics to destroy the infection, but the inflammation can persist and cause a great deal of pain. The hypothesis of this study is that adding a single dose of an oral steroid (prednisone), which tempers the immune response, will reduce inflammation, reduce pain, and speed recovery. This hypothesis will be examined by recruiting a group of patients with cellulitis, and randomizing them to two sub-groups: one group will receive a dose of prednisone, while the other group will receive a placebo. Neither group will know what they received unless there is a problem. These subjects will be followed up at the 48 hour mark and the 7 day mark, and will have their results compared.
详细描述
This pilot study will be conducted in a prospective, double-blinded, placebo-controlled, randomized fashion using a convenience sample of 100 subjects who come to the ED with signs and symptoms of cellulitis. Initial medical assessment will be made by an attending/senior resident according with established clinical procedures, including the history, physical examination, and vital signs. If by clinical assessment the patients meet eligibility criteria, then they will be approached by a research associate for screening, informed consent process, enrollment in the study, and data collection.
After the subjects understand and sign the informed consent form, they will be randomized to either the placebo group or treatment group. The EMCP pharmacy will be in charge of the randomization process. Once randomized, a standard source document (see data management section and appendix C for details) will be filled with information given by the subjects and in their charts. While study medication is given (time zero), subjects will receive a Visual Analog Scale (VAS) to rate their pain upon initial presentation along with determination of size of the cellulitic area. This will be done by determining the longest axis of the cellulitic area and measuring it (in mm) from the most proximal/lateral end towards the most distal/medial end, excluding any lymphangitic spread. The most proximal and distal area of erythema will be outlined.
While the standard treatment of care for cellulitis will be circumscribed according to already established protocols, the class of antibiotics and pain control that patients receive will depend on their disposition:
If discharged:
- Antibiotic prescriptions will be TMP/SMX 160/800 mg (Bactrim DS), 2 pills PO BID and Cephalexin 500 mg PO qid; if allergic, Clindamycin 300 mg PO QID.
- Pain control: during stay in the ED subjects will receive, according to their allergic history and as long as the treating physician determines it is necessary to address the pain, two tablets of either Percocet 5/325 mg,Vicodin 5/500 mg (if allergic to Percocet), or Acetaminophen 500 mg as an only dose. Once discharged they will receive, according to their allergic history and the physician's clinical judgement, a prescription of 12 tablets of either Percocet 5/325 mg, Vicodin 5/500 mg (if allergic to Percocet), Tylenol #3 300/30 mg, or Acetaminophen 500 mg, one tablet PO q6 and PRN for pain. Pain medication must not include NSAIDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Current episode of cellulitis
- •Erythema greater than 5 centimeters in any dimension
- •Pain, swelling, warmth, and tenderness in the area without elevated borders
- •Dispositioned for discharge from the Emergency Department or Observation
- •Able to consent
排除标准
- •Steroid use in the past 2 weeks
- •History of adrenal insufficiency
- •Any infection treated with antibiotics in the past 2 weeks
- •Allergy to:
- •Acetaminophen
- •Trimethoprim-Sulphamethoxazole (TMP/SMX), Cephalexin, and Clindamycin (must be allergic to all three for exclusion)
- •Oxycodone and Hydrocodone (must be allergic to both for exclusion)
- •If subject is going to the Observation unit, allergy to:
- •Clindamycin and Vancomycin (must be allergic to both for exclusion)
- •Morphine and Hydromorphone (must be allergic to both for exclusion)
- •Suspicion or presence of abscess
- •Suspicion or presence of deep vein thrombosis
- •Suspicion or presence of severe sepsis, as defined by:
- •Hypotension (systolic pressure < 90 mmHg or reduction of 40 mmHg from baseline)
- •Failure of single end organ
- •Suspicion or presence of septic shock, as defined by:
- •Severe sepsis
- •Hypotension that is refractory to fluid management
- •Failure or more than one end organ
- •Change in mentation
- •Tachycardia greater than 120 beats per minute
- •Fever greater than or equal to 39 degrees Celsius
- •Hospital admission
- •Under 18 years of age, or over 70 years of age
- •Pregnancy or breast feeding
- •Police custody or prisoner
- •Cognitive impairment
- •Inability to consent
- •Nursing home residents
研究组 & 干预措施
Placebo
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
干预措施: Placebo (Drug)
Prednisone
In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.
干预措施: Prednisone (Drug)
结局指标
主要结局
Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours
时间窗: Assessed once at day 1 and then once during the 48 hour follow-up
The level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes.
次要结局
- Amount of Pain Medication - 48 Hours to 7 Days(Assessed at the 48 hour follow-up and at the 7 day follow-up)
- Amount of Pain Medication - Day 1 to 7 Days(Assessed once during the 7 day follow-up)
- Amount of Pain Medication - Day 1 to 48 Hours(Assessed once during the 48 hour follow-up)
- Number of Participants Requiring Additional Medical Assistance Post-Randomization(Assessed continuously from day 1 to the day 7 follow-up call)
- Disposition Trend(Assessed once during day 1)
- Adverse Events (AE)(Assessed continuously from day 1 to day 7 follow-up)
- Change in Erythema Size - Day 1 to 48 Hours(Calculated once at 48 hrs)
研究者
Scott Goldstein, DO
Attending Physician
Albert Einstein Healthcare Network