| CTRI Number |
CTRI/2017/03/008090 [Registered on: 14/03/2017] Trial Registered Prospectively |
| Last Modified On: |
25/05/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to assess the comparative efficacy and
safety of a silver dressing against standard cotton dressing in the rate of Wound Healing after and operative procesure |
|
Scientific Title of Study
|
A prospective assessor-blind, randomized controlled clinical trial to assess the efficacy and
safety of Sterizone (an antimicrobial silver dressing) v/s standard cotton dressing in Post-
Operative Wound Healing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLIN-DP-ST Version 01 dated 01 July 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tripura Sundari M |
| Designation |
Principal Investigator |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Consultant and HOD
Dept.of Obstetrics and Gynaecology
Krishna Institute of Medical Sciences,Minister Rd, Krishna Nagar Colony,
Begumpet, Secunderabad, Telangana
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
|
| Fax |
|
| Email |
drsundari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tripura Sundari M |
| Designation |
Principal Investigator |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Consultant and HOD
Dept of Obstetrics and Gynaecology
Krishna Institute of Medical Sciences,Minister Rd, Krishna Nagar Colony,
Begumpet, Secunderabad, Telangana
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
|
| Fax |
|
| Email |
drsundari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreejith Sreekumar |
| Designation |
Chief Executive Officer |
| Affiliation |
Clinfound Clinical Research Services Pvt Ltd |
| Address |
Chief Executive Officer
Clinfound Clinical Research Services Pvt. Ltd
Chennal Buildings,
Kumaramangalam P O
Thodupuzha,
Kerala
Idukki
KERALA
685597
India |
| Phone |
9995342978 |
| Fax |
|
| Email |
drsreejith@clinfound.com |
|
|
Source of Monetary or Material Support
|
| Dynamic Techno Medicals Pvt Ltd,Ashokapuram,Aluva, Kerala 683101 |
|
|
Primary Sponsor
|
| Name |
Clinfound Clinical Research Services PvtLtd |
| Address |
Chennal Buildings,
Kumaramangalam, P O
Thodupuzha,
Kerala
685597 |
| Type of Sponsor |
Contract research organization |
|
|
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 |
| Dr Tripura Sundari M |
Krishna Institute of Medical Sciences |
Dept of Obstetrics and Gynecology
Minister Rd, Krishna Nagar Colony,Begumpet, Secunderabad, Telangana
500003
Hyderabad
ANDHRA PRADESH |
09885611977
drsundari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KFRC Ethics Committee KIMS Foundation and Research Center 1-8-31/1 Minister Road Secunderabad Telegana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
The subject is having surgery (Cesarean pfannenstiel or
Open Laparotomy incision) within 1 week, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Cotton Dressing |
This will be the standard care cotton dressing currently used at the site |
| Intervention |
Sterizone Silver Dressing |
Sterizone is an Anti-microbial Silver wound dressing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.The subject is willing and able to understand, sign and date the study Informed Consent, and
be able to adhere to the scheduled visits regimen.
2.The subject is having surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1
week |
|
| ExclusionCriteria |
| Details |
1.Patients with known allergy or topical
hypersensitivity to ionic silver or alginate
2. Any systemic or local active dermatological disease that might interfere with the
evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma,
chronic urticarial
3.Patients undergoing MRI (Magnetic Resonance Imaging) examination.
4.Subject residence is outside the study center city
5.Patients was participating in another clinical trial less than 30 days before participation in
this trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound infection rate within 5 days after operation |
Day 1,Day 3,Day 5 ,Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exudates absorption capacity |
Day 1,Day 3,Day 5,Day 30 |
| Stony Brooks scar evaluation scale |
Day 1,Day 3,Day 5 ,Day 30 |
| Wound keloid formation rate |
Day 5 ,Day 30 |
Patient and observer scar
assessment scale |
Day 5,Day 15,Day 30 |
| Photograph of the wound |
Day 1,Day 5,Day 15,Day 30 |
| Adverse events |
Day 1,Day 3,Day 5,Day 15 ,Day 30 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/03/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a A prospective assessor-blind, randomized controlled clinical trial to assess the efficacy and safety of Sterizone (an antimicrobial silver dressing) v/s standard cotton dressing in Post-Op Wound Healing.100 patients who will undergo surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week will be recruited from KIMS Hospital,Hyederabad, OBG and Gynec Department.Patients with confirmed eligibility will be randomized into two groups. One group will receive Sterizone Silver Dressing and the other group standard cotton dressing for wound healing. Both groups will be followed up for 30 days over 4 visits.The primary objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of Sterizone (an antimicrobial silver dressing) role in obstetrical and gynecological wound healing is as effective and safe as Standard cotton dressing. The secondary objective is to assess the safety parameters |