| CTRI Number |
CTRI/2024/03/063904 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of factors which will determine outcome in patients with infection of limbs |
|
Scientific Title of Study
|
Predictors of outcome in limb cellulitis with/without deep soft tissue infection
presenting to the Emergency Medicine department of a tertiary care centre in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prithvishree Ravindra |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE, Manipal |
| Address |
Department of Emergency Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9035296971 |
| Fax |
|
| Email |
prithvishree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prithvishree Ravindra |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE, Manipal |
| Address |
Department of Emergency Medicine, Kasturba Medical College, Manipal
KARNATAKA
576104
India |
| Phone |
9035296971 |
| Fax |
|
| Email |
prithvishree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Safa Abubacker |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College, Manipal, MAHE, Manipal |
| Address |
Department of Emergency Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9605728997 |
| Fax |
|
| Email |
safa.aboobacker@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine, Kasturba Medical College, Manipal, Udupi, Karnataka- 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Prithvishree Ravindra |
| Address |
Department of Emergency Medicine, Kasturba Medical College, Manipal, Udupi, Karnataka- 576104 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prithvishree Ravindra |
Kasturba Hospital, Manipal |
Ground floor, Trauma and emergency block, Department of Emergency Medicine, Kasturba Medical College and Hospital, tiger circle, Madhavnagar, Manipal
Udupi
KARNATAKA |
9035296971
prithvishree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2 (Student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L039||Cellulitis and acute lymphangitis,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with unilateral redness, warmth and edema of limbs suggestive of cellulitis
|
|
| ExclusionCriteria |
| Details |
Patient with cellulitis more than 2 weeks, patients not consenting to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 7 day Mortality ( Survived / Dead ) |
At day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 28 day Mortality (Survived/Dead) |
At day 28 |
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims to analyse the clinical as well as laboratory parameters that have a direct impact on the prognosis of patients having limb cellulitis with/without deep soft tissue infections. After informed consent, patient coming to the Emergency Medicine Department meeting the inclusion criteria will be enrolled. Their admission vital signs and examination findings will be noted. The lab investigations will be sent as per treating physicians’ discretion. The reports of the lab investigations will be collected as per the data collection tool. The patients will be followed up through the admission for parameters such as time to first antibiotic, time to surgery, treatment given, 7 day mortality, outcome. Microbiological diagnosis will be noted. At discharge, the ventilator requirement, oxygen requirement, vasopressor requirement, mortality will be noted. Patients discharged prior to 28 days, will have a telephonic follow up to 28-day mortality. |