Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
Condition: Cellulitis
MeSH terms: Cellulitis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. 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.

        2. 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.

      If admitted to observation unit: antibiotics will be IV Clindamycin 300 mg q6 hours; if
      allergic, IV Vancomycin 1 g q12 hours should be given. For pain control: Morphine 4 mg IV q4
      hours and PRN pain; if allergic, Dilaudid 1 mg IV q4 hours and PRN if pain. Pain medication
      must not include NSAIDs. Once discharged, they will receive the same prescription as the
      discharged group of subjects.

      In addition to the standard of care described and any additional medications deemed
      appropriate by the attending physician that do not represent a confounding factor to the
      study (NSAIDs, other antibiotics), subjects will also receive an additional pill which will
      be either prednisone 60 mg or placebo. If the treating physician feels it is in the best
      interest of the subject to break the protocol, the subject's participation in study
      procedures will end. Data that has already been collected will be kept, and may be analyzed
      separately. Once the subjects have received the study medications, they will follow their
      dispositions (either be discharged or be admitted in the observation's unit). To assure
      treatment compliance, the Research Associate will provide the subjects with antibiotics and
      pain medication treatment corresponding to the first 48 hours. After this landmark, the
      subjects will cover the rest of their treatment. Subjects will be instructed not to take any
      medication outside the prescription during the length of the study. If the subjects take
      NSAIDs during the first 48 hours, this could be considered a confounding factor. As such,
      subjects who take NSAIDs within the first 48 hours will have their participation in study
      procedures ended. Their already collected data will be kept and may be analyzed separately;
      however, if they take NSAIDs after the 48-hour visit their study participation will continue.

      Subjects will be required to return to the ED after 48 hours and bring the remaining
      prescribed pain medications. They will meet a Research Associate for re-evaluation, which
      will be done by using a VAS, measuring the cellulitic area, and assessing the degree of usage
      of the prescribed pain medications. This second visit is not part of the standard of care so
      patients won't be required to receive a formal evaluation by an ED doctor nor register in
      triage. Financial compensation will be provided on completion of the 48 hour follow-up visit
      for all patients. A seventh (± one) day follow-up call will be done to assess pain severity,
      degree of symptomatic recovery and disappearance of the erythema, and need of additional
      medical assistance.
    

Intervention name(s): Prednisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See "Prednisone" arm description; See "Placebo" arm description
Other intervention name(s): Deltasone; Prednicot; Sterapred; Sugar Pill; Inactive Drug; Control
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cellulitis; Skin infection; Prednisone; Steroid; Anti-inflammatory