An interventional study of Prednisone and Placebo in Cellulitis, sponsored by Albert Einstein Healthcare Network. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by Albert Einstein Healthcare Network · Not applicable, Interventional, and Supportive care
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.
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:
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.
160 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's enrollment of 42 is below the median of 157 across 124 interventional studies indexed under Cellulitis.
Browse Cellulitis studies →Albert Einstein Healthcare Network is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Current episode of cellulitis
Exclusion Criteria:
Allergy to:
If subject is going to the Observation unit, allergy to:
Suspicion or presence of severe sepsis, as defined by:
Suspicion or presence of septic shock, as defined by:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.
Drug: Prednisone
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
Drug: Placebo
See "Prednisone" arm description
Also known as: Deltasone, Prednicot, Sterapred
See "Placebo" arm description
Also known as: Sugar Pill, Inactive Drug, Control
Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours
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.
Time frame: Assessed once at day 1 and then once during the 48 hour follow-up
Amount of Pain Medication - Day 1 to 48 Hours
Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up
Time frame: Assessed once during the 48 hour follow-up
Amount of Pain Medication - Day 1 to 7 Days
Total amount of pain medication used between day 1 and the 7 day follow-up call.
Time frame: Assessed once during the 7 day follow-up
Amount of Pain Medication - 48 Hours to 7 Days
Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up.
Time frame: Assessed at the 48 hour follow-up and at the 7 day follow-up
Number of Participants Requiring Additional Medical Assistance Post-Randomization
Need for additional medical intervention to treat the current episode of cellulitis.
Time frame: Assessed continuously from day 1 to the day 7 follow-up call
Disposition Trend
Disposition of the subject at the end of the initial visit on day 1; "Disposition Trend" refers to whether the subject was discharged to home or admitted to observation unit in the hospital. This Outcome Measure intends to assess improvement from baseline following intervention.
Time frame: Assessed once during day 1
Adverse Events (AE)
Development of adverse events during study period such as: allergic reaction, development of severe sepsis or septic shock, crepitus, change in mentation, fever greater than or equal to 39 degrees Celsius, tachycardia (heart rate over 120 beats per minute)
Time frame: Assessed continuously from day 1 to day 7 follow-up
Change in Erythema Size - Day 1 to 48 Hours
Change in erythema size - day 1 to 48 hours = (Mean erythema at Day 1) - (Mean erythema at 48 hrs) Erythema is measured in millimeters using the most proximal and distal area of the erythema. Higher values represent worse outcome.
Time frame: Calculated once at 48 hrs
| Milestone | Prednisone | Placebo |
|---|---|---|
| Started | 20 | 20 |
| Completed | 14 | 9 |
| Not completed | 6 | 11 |
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.
| score on a scale | Prednisone | Placebo |
|---|---|---|
| VAS at Day 1 | 79.64 ± 14.89 | 56.45 ± 30.25 |
| VAS at 48 hrs | 39.71 ± 34.5 | 25.91 ± 33.25 |
Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up
| medications taken | Prednisone | Placebo |
|---|---|---|
| Amount of Pain Medication - Day 1 to 48 Hours | 7 (0 to 16) | 2 (0 to 12) |
Total amount of pain medication used between day 1 and the 7 day follow-up call.
No measurements were reported for this outcome.
Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up.
No measurements were reported for this outcome.
Need for additional medical intervention to treat the current episode of cellulitis.
No measurements were reported for this outcome.
Disposition of the subject at the end of the initial visit on day 1; "Disposition Trend" refers to whether the subject was discharged to home or admitted to observation unit in the hospital. This Outcome Measure intends to assess improvement from baseline following intervention.
| Participants | Prednisone | Placebo |
|---|---|---|
| Discharged to Home | 12 | 8 |
| Data not available/not collected | 2 | 3 |
Development of adverse events during study period such as: allergic reaction, development of severe sepsis or septic shock, crepitus, change in mentation, fever greater than or equal to 39 degrees Celsius, tachycardia (heart rate over 120 beats per minute)
No measurements were reported for this outcome.
Change in erythema size - day 1 to 48 hours = (Mean erythema at Day 1) - (Mean erythema at 48 hrs) Erythema is measured in millimeters using the most proximal and distal area of the erythema. Higher values represent worse outcome.
No measurements were reported for this outcome.
Collected over Adverse events collected upto 7 day follow up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prednisone | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Placebo | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
Of the 40 subjects that were randomized, 25 subjects were analyzed; 14 received prednisone, 11 received placebo
| Age, Continuous(Years) | Prednisone | Placebo | Total |
|---|---|---|---|
| Mean | 40 (21 to 58) | 40 (18 to 66) | 40 (18 to 66) |
| Sex: Female, Male(Participants) | Prednisone | Placebo | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 9 | 5 | 14 |
Plan to share: No
The record gives a start of Aug 2012, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2021, 5 years 5 months after primary completion.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prednisone
Albert Einstein Healthcare Network