| 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
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
|
| Type of Sponsor |
|
|
|
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 |
| 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
|
|
|
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
|
|