CTRI Number |
CTRI/2010/091/001198 [Registered on: 05/10/2010] |
Last Modified On: |
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Post Graduate Thesis |
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Type of Trial |
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Type of Study
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Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
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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
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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 |
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Secondary IDs if Any
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Secondary ID |
Identifier |
NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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Name |
Urvashi vats |
Designation |
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Affiliation |
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Address |
LTMMC, SION
Mumbai MAHARASHTRA
India |
Phone |
919559493008 |
Fax |
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Email |
urvashision@rediffmail.com |
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Details of Contact Person Scientific Query
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Name |
suchitra pandit |
Designation |
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Affiliation |
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Address |
LTMMC, SION
Mumbai MAHARASHTRA
India |
Phone |
09820416474 |
Fax |
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Email |
suchipan56@rediffmail.com |
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Details of Contact Person Public Query
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Name |
Urvashi vats |
Designation |
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Affiliation |
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Address |
LTMMC, SION
Mumbai MAHARASHTRA
India |
Phone |
919559493008 |
Fax |
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Email |
urvashision@rediffmail.com |
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Source of Monetary or Material Support
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Primary Sponsor
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Name |
nil |
Address |
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Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
Sites of Study
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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 |
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Details of Ethics Committee
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No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethics committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
role of suture material as subcuticular skin stitches, |
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Intervention / Comparator Agent
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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 |
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Inclusion Criteria
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Age From |
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Age To |
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Gender |
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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 |
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ExclusionCriteria |
Details |
1. previous abdominal surgeries
2. medical illness(koch's bronchial asthama,hypertension,diabetes,hematological disorders)
3. skin infections |
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Method of Generating Random Sequence
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Computer generated randomization |
Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
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Open Label |
Primary Outcome
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Outcome |
TimePoints |
wound discharge,pain,scar line |
4th day,10th day,15th day, 1 mth,3mth,6 mth |
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Secondary Outcome
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Outcome |
TimePoints |
death |
6 month |
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Target Sample Size
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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
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Phase 4 |
Date of First Enrollment (India)
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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
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Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
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Completed |
Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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