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CTRI Number  CTRI/2023/05/052614 [Registered on: 15/05/2023] Trial Registered Prospectively
Last Modified On: 12/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective study 
Study Design  Other 
Public Title of Study   Clinical outcomes of Mucormycosis 
Scientific Title of Study   A mixed method study to explore the clinical outcomes among patients with ororhino orofacial and maxillary mucormycosis admitted at tertiary care centre,Jaipur (Rajasthan) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIRENDRA SINGH 
Designation  NURSING TUTOR 
Affiliation  GOVERNMENT COLLEGE OF NURSING,SIKAR(RAJ) 
Address  DEPT OF PSYCHIATRIC NURSING,GOVERNMENT COLLEGE OF NURSING. GNMTC BUILDING, PIPRALI SIKAR,(RAJASTHAN)
S.K.GOVERNMENT MEDICAL COLLEGE,SIKAR RAJASTHAN
Sikar
RAJASTHAN
302027
India 
Phone  09460103856  
Fax    
Email  SINGHVIRENDRA809@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashidhara YN 
Designation  Professor and HOD, Dept of Community Health Nursing 
Affiliation  MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL KARNATAKA 
Address  Department of Community Health Nursing Manipal College of Nursing, MAHE Manipal
Department of Community Health Nursing Manipal College of Nursing, MAHE Manipal KARNATAKA
Udupi
KARNATAKA
576104
India 
Phone  09886344627  
Fax    
Email  shashidhara.yn@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  VIRENDRA SINGH 
Designation  NURSING TUTOR 
Affiliation  GOVERNMENT COLLEGE OF NURSING,SIKAR(RAJ) 
Address  DEPT OF PSYCHIATRIC NURSING,GOVERNMENT COLLEGE OF NURSING. GNMTC BUILDING, PIPRALI SIKAR,(RAJASTHAN)
S.K.GOVERNMENT MEDICAL COLLEGE,SIKAR RAJASTHAN
Sikar
RAJASTHAN
302027
India 
Phone  09460103856  
Fax    
Email  SINGHVIRENDRA809@GMAIL.COM  
 
Source of Monetary or Material Support  
RUHS COLLEGE OF DENTAL SCIENCES AND HOSPITAL,JAIPUR (RAJASTHAN) 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [Self Sponsored] 
 
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 
VIRENDRA SINGH  RUHS COLLEGE OF DENTAL SCIENCES AND HOSPITAL, JAIPUR (RAJASTHAN)R d  Department of oral Maxillo facial surgery. Department no. -2 AND WARD OF ORAL MAXILO FACIAL SURGERY . FIRST FLOOR RUHS COLLEGE OF DENTAL HOSPITAL
Jaipur
RAJASTHAN 
9460103856

Singhvirendra809@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
OFFICE OF THE ETHICS COMMITTEE, RUHS COLLEGE OF DENTAL SCIENCES,SUBHASH NAGAR,JAIPUR302016   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B088||Other specified viral infections characterized by skin and mucous membrane lesions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  For Qualitative Study sample will selected for study who full fill following criteria
Biopsy Proved Mucormycosis patient.
Patient who are admitted at RUHS College of Dental Science Jaipur
Patient with or without history of COVID 19 .
Patient who will admitted at the time of data collection. Or discharged from hospital within 3 days or near about to discharge.
Patient who respond to question during collection of qualitative data.
If Patient unable to respond due to surgical procedure then get information from care giver.
 
 
ExclusionCriteria 
Details  For Qualitative study patient will excluded from study-
Patient who discharged from hospital and more than 3 days.
Patient have another Oral cavity complication from long time before getting mucormycosis infection.Patient who not willing to participate study.
Patient with Mucormycosis involed other than Orofacial area.
Children are excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore the experiences regarding clinical outcome in terms of physical, social and psychological disturbances among the patients with mucormycosis.   6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
find out the association between mucormycosis and selected variables (age, gender, COVID -19 ) among the patients with mucormycosis.  6 Months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   17/05/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

BACKGROUND-

Mucormycosis (formerly known as zygomycosis) is an uncommon, opportunistic fungal infection primarily caused by Mucorales, a filamentous fungus of the Mucormycetes class. Mucormycosis is a rare but devastating fungal infection primarily affecting immunocompromised patients such as those with hematological malignancy, bone marrow and solid organ transplantation, and patients with diabetes, and, even more rarely, immune competent patients.

(Dimitrios P. Kontoyiannis2016 )

Mucormycosis is an angiovasive infection caused by the ubiquitous filamentous fungi of the  order Mucorales and class of  Mucormycetes. Mucormycosis is emerging infection in COVID 19 Pandemic Era.(George Petrikkos, Anna Skiad 2021)

Thus all review and studies supported tha mucormycosis is a very dangerous infection among the patient with history of COVID19,DM, Immunocompromised condition .All these studies show many clinical outcomes in forms of disturbances among the patients  inspite of taking treatment. Mucormycosis is emerging health issue as in COVID 19 Pandemic era so it is important to conduct the research study on this problem . In India there are very less no of research studies conducted on such emerging problem.

PURPOSE OF STUDY –

The  Study aims to investigate the clinical feature of mucormycosis, History of  COVID 19 and specific system disorder and treatment outcome of admitted patients . This will help in find out  the association of contributing factors and clinical outcome of patient as  well as development of intervention  according the need of patient .

The study also  aims to assess the prospective clinical outcome in form of physical , psychological and social  status  among patients admitted for    treatment of mucormycosis  .These outcomes will helpful in development of intervention of physical, psychological and social dimension  of care of patient with mucormycosis.

 
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