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CTRI Number  CTRI/2024/07/070030 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study of pattern of clinical presentation and 
 management of skin and soft tissue infection 
Scientific Title of Study   Study of pattern of clinical presentation and management of skin and soft tissue infection in a tertiary care rural hospital 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  Dr Deepanshu Sharma  
Designation  Junior Resident  
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  General Surgery Department, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9971098696  
Fax    
Email  deepanshu199914@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Imran Ali Khan  
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  General Surgery Department, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9822708147  
Fax    
Email  drimk@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Imran Ali Khan  
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  General Surgery Department, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9822708147  
Fax    
Email  drimk@rediffmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra 442001 
 
Primary Sponsor  
Name  Dr Deepanshu Sharma  
Address  General Surgery Department, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra 442001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepanshu Sharma   Acharya Vinoba Bhave Rural Hospital  Ward 42-43-44-45, Department of General Surgery, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra 442001
Wardha
MAHARASHTRA 
9971098696

deepanshu199914@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  (1)ICD 10 CONDITION: MEDICAL AND SURGICAL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NO INTERVENTION  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients presenting with skin and soft tissue infections of any gender.
Patients above 18 years of age with or without comorbidities.
Patient less than 18 years of age referred to the Department of surgery
Patients with infection of any etiology
 
 
ExclusionCriteria 
Details  Patient not willing to participate in the study .
Patient on steroids
Patients with malignancy
HHH positive patients
Pregnant females
Patients with psychiatric illness  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
clinical presentation of skin and soft tissue infection   16-34 months 
 
Secondary Outcome  
Outcome  TimePoints 
management outcome of skin and soft tissue infection  16-34 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   24/07/2024 
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="1"
Months="5"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Skin and Soft-tissue infections are frequent, usually mild to moderate in intensity, and

easily treated with a range of medications.Common simple SSTIs include

cellulitis, folliculitis, furuncles, carbuncles, abscesses, and trauma-related

infections that are generally easily treatable. Complicated infections extending into

and involving the underlying deep tissues include deep abscesses, decubitus ulcers,

necrotising fasciitis, Fournier gangrene, and infections from human or animal bites.

Most simple SSTIs resolve automatically.Large, complex, and painful SSTIs

require medical attention.Depending on the severity of the infection, they may need

antibiotics, suction with a syringe, incision and drainage (I/D), debridement and

drainage (D/D), amputation or even surgery may be required


Diagnosis of these infections is mostly clinical. Guidelines suggest that CBC and

wound culture should be ordered for all complicated SSTIs, and for those with sepsis

should be ordered for blood culture as well . These tests can be avoided in

uncomplicated infections.


Necrotising soft-tissue infections , or NSTIs, are extremely deadly. The degree of

organ system failure at the time of admission, age, length of infection, delayed initial

debridement, and decreased renal function are among the risk factors for death in

these cases. Treating patients with NSTI can sometimes be most challenging when it

comes to establishing the diagnosis, and early and accurate diagnosis depends onamputations are performed on diabetic patients, with chronic DFU being one of the

most common reasons for hospitalisation in this population.


Mono-microbial infections are mainly caused by haemolytic Group A Streptococcus,

Staphylococcus aureus, or clostridial species[7]. Younger people and the extremities

are affected by group A streptococcal infections, which are linked to a streptococcal

toxic shock-like syndrome.


In order to assist clinicians in determining the severity of an infection, a number of

classification methods and algorithms have been presented. Nonetheless, the majority

of clinical evaluations have been derived from either retrospective research or the

author’s personal "clinical experience," highlighting the necessity of conducting

prospective studies that include outcomes and management considerations in addition

to established severity levels.


We try to assess all the clinical circumstances related to soft-tissue infections in this

study, including the prognosis, therapy and their management outcomes.

 
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