Clinical Trials Logo

Clinical Trial Summary

Cellulitis is an increasingly common and unpleasant bacterial infection of the skin, usually affecting the legs. Patients experience pain and swelling, loss of mobility, fever, and chills. Patients may be left with chronic skin damage and 1 in 5 experience recurrences. Cellulitis is treated with antibiotics, but it is unclear as to how long treatment should be for. As a result, many patients get much longer antibiotic treatment than needed. This exposes patients to the risks of taking unnecessary antibiotics. This study aims to find out what features of individual patients predict a good, sustained recovery from cellulitis. These may include medical conditions and clinical response to the first few days of antibiotic treatment, such as changes in skin temperature. Patients who are being treated in hospital for cellulitis will be invited to take part. Information will be collected about patients who will be followed up for 3-6 months. Devices for measuring skin temperature will also be compared to see which one works best. This information will be used to help develop a set of rules that doctors can use to guide the length of antibiotic treatment. This should ensure that future patients receive the amount of antibiotics needed and no more.


Clinical Trial Description

This study is a single centre prospective cohort study of patients with cellulitis of the lower limb. The primary objective of this study is to understand what features of individual patients predict a sustained recovery from cellulitis. This information will be used to test and refine a previously developed risk score that predicts clinical outcomes of patients with cellulitis. Secondary objectives include investigating whether early response to antibiotic treatment (e.g. reduction in skin temperature and patient-reported symptoms) improves the predictive ability of the risk score. The study design also includes a nested technology comparison of temperature measurement devices to identify the best device for measuring affected skin temperature change in patients with cellulitis. Clinical response will be measured for up to four days from starting antibiotic treatment. This includes the change in temperature and area of affected skin, physiological observations, blood test results (e.g. C-reactive protein) and patient-reported pain and swelling scores. Patients will be followed up at 28 and 90 days (+/- 180 days for those recruited in the first year) to assess recovery, recurrence, cellulitis-related mortality, quality of life, and return to normal activities. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05023200
Study type Observational
Source University of Sussex
Contact
Status Completed
Phase
Start date June 9, 2021
Completion date September 2, 2023

See also
  Status Clinical Trial Phase
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT00746109 - Study of Wound Packing After Superficial Skin Abscess Drainage Phase 4
Completed NCT03296280 - Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
Completed NCT01876628 - Adjunctive Clindamycin for Cellulitis: C4C Trial. Phase 4
Not yet recruiting NCT01947660 - Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery N/A
Active, not recruiting NCT01706913 - Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis N/A
Completed NCT03474523 - Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment N/A
Recruiting NCT03312946 - Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite. N/A
Active, not recruiting NCT05226260 - Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care N/A
Active, not recruiting NCT03785834 - The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis
Completed NCT01549613 - Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections Phase 4
Completed NCT01029782 - Comparison of Intravenous Cefazolin Plus Oral Probenecid With Oral Cephalexin for the Treatment of Cellulitis Phase 2
Completed NCT00676130 - Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients N/A
Not yet recruiting NCT03917134 - Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy N/A
Completed NCT02230813 - Predictors of Oral Antibiotic Treatment Failure in Emergency Department Patients With Cellulitis N/A
Completed NCT01557426 - Soft Tissue Ultrasound of Infections Phase 1
Completed NCT01339091 - Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Phase 3
Completed NCT00984022 - Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage Phase 2
Completed NCT04091672 - RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction N/A
Terminated NCT02087527 - Use of Corticosteroids in Children With Cellulitis N/A