| CTRI Number |
CTRI/2018/07/014979 [Registered on: 20/07/2018] Trial Registered Prospectively |
| Last Modified On: |
09/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of sutures for skin closure in cesarean section |
|
Scientific Title of Study
|
A Randomized controlled trial comparing poliglecapreone-25 and polyglactin-910 for subcuticular skin closure in cesarean section. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shikha Sharma |
| Designation |
Post graduate student |
| Affiliation |
Dr Rajendra Prasad govt medical college kangra at tanda |
| Address |
Department of OBG
Dr Rajendra Prasad govt medical college kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8988335505 |
| Fax |
|
| Email |
sharmashikha1178@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali soni |
| Designation |
Professor |
| Affiliation |
Dr Rajendra Prasad govt medical college kangra at tanda |
| Address |
Department of OBG
Dr Rajendra Prasad govt medical college kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
anjalisoni19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali soni |
| Designation |
Professor |
| Affiliation |
Dr Rajendra Prasad govt medical college kangra at tanda |
| Address |
Department of OBG
Dr Rajendra Prasad govt medical college kangra at tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
anjalisoni19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of OBG
Dr Rajendra Prasad govt medical college kangra at tanda |
|
|
Primary Sponsor
|
| Name |
Department of OBG |
| Address |
Dr Rajendra Prasad govt medical college kangra at tanda |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shikha Sharma |
Antenatal ward/labour ward |
Department of OBG
Dr Rajendra Prasad govt medical college
Kangra
HIMACHAL PRADESH |
8988335505
sharmashikha1178@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rajendra Prasad govt medical college Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnant women at period of gestation more than 37 weeks, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Subcuticular suture application for skin closure in cesarean section |
Two suture materials Poliglecapreone-25 and polyblactin -910 are compared
For wound complications,pain and cosmetic appearance. |
| Comparator Agent |
Subcuticular suture materials |
Poliglecapreone-25 is compared with polyglactin 910 for wound complications,pain and cosmetic appearance of scar |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy
Period of gestation more than 37 complete d weeks |
|
| ExclusionCriteria |
| Details |
Vertical skin incision
Premature rupture of membranes
Chorioamniotis
Intauterine fetal death
Utu within 2 weeks before CS
Frank sepsis
BMI more than 35
Emergency CS requiring urgent fetal delivery
Situations where antibiotic could not be given at least 30 min before skin incision
Diabetes mellitus on insulin
Local skin infection at site of incision
General anesthesia
Use of systemic steroids during pregnancy for 2 weeks or greater
Any chronic medical illness
Frank sepsis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Composite wound complications as defined by CDC |
Pain at day 3
Scar at 6 weeks post operatively
Wound infection at any time up to 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
Cosmetic appearance |
Pain on day 3
Cosmetic appearance at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/08/2018 |
| 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="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cesarean Section is a common procedure and till now consensus on skin closure tachniques remain elusive. common skin closure techniques are are Subcuticular sutures and Staples. Among sutures two most widely used sutures for low transverse cesarean section skin closure are poligPoliglecapreo and polyblactin -910. As there is difference in profile for each suture and physiologic wound healing process,present study is planned to evaluate these two suture materials for subcuticular skin closure. |