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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR300952 | Other Identifier | NIHR Doctoral Fellowship | |
| 295690 | Other Grant/Funding Number | IRAS |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population | Adults (age ≥18 years) identified by their treating clinician as having lower limb cellulitis that requires intravenous or oral antibiotic treatment either from the hospital or another service based outside of the hospital, which will conduct ongoing follow-up regardless of location. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sustained Recovery | Number of Participants with Sustained Recovery | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cellulitis-related Readmission | Number of participants with new hospital admission/reattendance containing a cellulitis diagnostic code | 90 days |
| Recovery at 28 Days | Number of participants who recovered within 28 days (investigator assessed) |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability Coefficient | Repeatability, defined as the consistency of measurements when taken repeatedly at short intervals by the same device under the same conditions, was assessed by calculating the repeatability coefficient. The repeatability coefficient and estimated 95% Confidence Interval were calculated from one temperature measurement and an instant repeated temperature measurement of the limb of interest on each participant on days 0, 1, 2, 3, all combined. The repeatability coefficient can be interpreted as the range (between the negative and positive values of the coefficient) within which the difference between any two repeated measurements on the same subject is expected to lie for 95% of subjects. |
Inclusion Criteria:
Exclusion Criteria:
Patients:
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Hospital-based or services delivering antibiotic treatment and ongoing follow-up regardless of location.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth LA Cross | University of Sussex | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Sussex NHS Foundation Trust | Brighton | United Kingdom |
Anonymised study data is intended to be made available via an open access research database.
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230 recruited:
13 excluded
10 died within 90 days before recurrence
4 withdrew
1 loss to follow-up
202 included in final analysis
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort | Main cohort |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort | Main cohort |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sustained Recovery | Number of Participants with Sustained Recovery | Posted | Count of Participants | Participants | 90 days |
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Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed
Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort | Main cohort | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Elizabeth Cross | Brighton and Sussex Medical School | +44 (0)1273 877889 | E.Cross1@bsms.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2023 | Dec 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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| 28 days |
| Patient-reported Recovery by 28 Days | Number of patients recovered within 28 days (patient-reported) | 28 days |
| Time to Return to Work / Normal Activities | Number of patients who reported they had returned to work / normal activities within 90 days | Baseline to 90 days |
| Change in Physical Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) | The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health. | Baseline to 90 days |
| Change in Mental Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) | The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health. | Baseline to 90 days |
| Measurements taken at 0 to 3 days |
| Limits of Agreement | The mean represents the estimated mean difference in affected-limb temperature between measurement methods; the reported 95% interval corresponds to the limits of agreement. | Measurements taken at 0 to 3 days |
| Lost to Follow-up |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Patient-reported previous cellulitis | Count of Participants | Participants |
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| Secondary | Cellulitis-related Readmission | Number of participants with new hospital admission/reattendance containing a cellulitis diagnostic code | Posted | Count of Participants | Participants | 90 days |
|
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| Secondary | Recovery at 28 Days | Number of participants who recovered within 28 days (investigator assessed) | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Patient-reported Recovery by 28 Days | Number of patients recovered within 28 days (patient-reported) | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Time to Return to Work / Normal Activities | Number of patients who reported they had returned to work / normal activities within 90 days | Posted | Count of Participants | Participants | Baseline to 90 days |
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| Secondary | Change in Physical Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) | The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Baseline to 90 days |
|
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| Secondary | Change in Mental Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) | The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Baseline to 90 days |
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| Other Pre-specified | Repeatability Coefficient | Repeatability, defined as the consistency of measurements when taken repeatedly at short intervals by the same device under the same conditions, was assessed by calculating the repeatability coefficient. The repeatability coefficient and estimated 95% Confidence Interval were calculated from one temperature measurement and an instant repeated temperature measurement of the limb of interest on each participant on days 0, 1, 2, 3, all combined. The repeatability coefficient can be interpreted as the range (between the negative and positive values of the coefficient) within which the difference between any two repeated measurements on the same subject is expected to lie for 95% of subjects. | Posted | Number | 95% Confidence Interval | Repeatability coefficient | Measurements taken at 0 to 3 days | Affected limb measurements | Affected limb measurements |
|
|
|
| Other Pre-specified | Repeatability Coefficient | Repeatability, defined as the consistency of measurements when taken repeatedly at short intervals by the same device under the same conditions, was assessed by calculating the repeatability coefficient. The repeatability coefficient and estimated 95% Confidence Interval were calculated from one temperature measurement and an instant repeated temperature measurement of the limb of interest on each participant on days 0, 1, 2, 3, all combined. The repeatability coefficient can be interpreted as the range (between the negative and positive values of the coefficient) within which the difference between any two repeated measurements on the same subject is expected to lie for 95% of subjects. | Posted | Number | 95% Confidence Interval | Repeatability coefficient | Measurements taken at 0 to 3 days | Unaffected limb measurements | Unaffected limb measurements |
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| Other Pre-specified | Limits of Agreement | The mean represents the estimated mean difference in affected-limb temperature between measurement methods; the reported 95% interval corresponds to the limits of agreement. | Posted | Mean | 95% Confidence Interval | Degrees celsius | Measurements taken at 0 to 3 days |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |