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CTRI Number  CTRI/2010/091/001198 [Registered on: 05/10/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare the efficacy of different suture material polyglactine violet, monofilament polyamide & monofilament poliglecaprone as subcuticular stiches on skin closure of post operative patients. 
Scientific Title of Study   To compare the efficacy of different suture material polyglactine violet, monofilament polyamide & monofilament poliglecaprone as subcuticular stiches on skin closure of post operative patients.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Urvashi vats 
Designation   
Affiliation   
Address  LTMMC, SION

Mumbai
MAHARASHTRA

India 
Phone  919559493008  
Fax    
Email  urvashision@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  suchitra pandit 
Designation   
Affiliation   
Address  LTMMC, SION

Mumbai
MAHARASHTRA

India 
Phone  09820416474  
Fax    
Email  suchipan56@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Urvashi vats 
Designation   
Affiliation   
Address  LTMMC, SION

Mumbai
MAHARASHTRA

India 
Phone  919559493008  
Fax    
Email  urvashision@rediffmail.com  
 
Source of Monetary or Material Support  
nil 
nil 
nil 
 
Primary Sponsor  
Name  nil 
Address   
Type of Sponsor   
 
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 
URVASHI VATS  deptt. of obst. & gynecology, LOK MANAY TILAK MUNICIPAL MEDICAL COLLEGE  ,-
Mumbai
MAHARASHTRA 
09559493008

urvashision@rediffmail.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 
Patients  role of suture material as subcuticular skin stitches,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  poliglactin  used as subcuticular skin stitches in post lscs patients 
Intervention  poliglecaprone suture  used as subcuticular skin stitches in post lscs patients 
Intervention  polyamide suture  used as subcuticular skin stitches in post lscs patients 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1.hb >10gm% 2.all cesarean section done on emergency bases in same operation theatre 3.same technique of cesarean section used 4. cesarean section done by qualified obstetricians 
 
ExclusionCriteria 
Details  1. previous abdominal surgeries 2. medical illness(koch's bronchial asthama,hypertension,diabetes,hematological disorders) 3. skin infections 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
wound discharge,pain,scar line  4th day,10th day,15th day, 1 mth,3mth,6 mth 
 
Secondary Outcome  
Outcome  TimePoints 
death   6 month 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="" 
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   Phase 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  04/01/2008 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary    
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