| CTRI Number |
CTRI/2024/02/063156 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Silk fibroin powder dressing in Superficial surgical site infections(SSI) in abdomen surgeries when compared to Saline dressings in wound healing. |
|
Scientific Title of Study
|
Effectiveness of Silk fibroin powder dressing in Superficial surgical site infections(SSI) in post laparotomy wounds when compared to Saline dressings in wound healing. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandavaram Bhanu Prakash |
| Designation |
Junior Resident |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
| Address |
Surgery department, 2nd floor,old block, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER),Dhanvantri nagar,
Puducherry-605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7207693553 |
| Fax |
|
| Email |
bhanucprakash1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Shamrao Kumbhar |
| Designation |
professor |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
| Address |
Surgery department, 2nd floor,old block, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER),Dhanvantri nagar,
Puducherry-605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9940306508 |
| Fax |
|
| Email |
K26uday74@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Shamrao Kumbhar |
| Designation |
professor |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
| Address |
Surgery department, 2nd floor, old block, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Dhanvantri Nagar,
Puducherry-605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9940306508 |
| Fax |
|
| Email |
K26uday74@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) hospital and institue |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education Research JIPMER |
| Address |
Surgery Department, 2nd floor, old block, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER),Dhanvantri nagar,
Puducherry-605006
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 CHANDAVARAM BHANU PRAKASH |
JIPMER HOSPITAL, JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
SURGERY
DEPARTMENT, 2 nd
floor , old
block,JIPMER,
DHANVANTARI
NAGAR ,
PUDUCHERRY-60500
6
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
7207693553
bhanucprakash1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jipmer Institutional Ethics Committe Interventional studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application of silk fibroin powder
on surgical site infections in
post laparotomy patients |
Application of silk fibroin powder
on surgical site infections in
post laparotomy patients and
assess wound on 5 th , 10 th
and 15 th day |
| Comparator Agent |
normal saline dressing in
superficial surgical site
infections in post laparotomy
patients |
Application of normal saline
dressing in superficial ssi in post
laparotomy patients and
asssessing wound on 5 th ,10 and 15 th day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Consenting post midline laparotomy patients with age more than 18
yrs having superficial SSI with wound dehiscence |
|
| ExclusionCriteria |
| Details |
1.supericial ssi with wound dehiscence of more than 2 weeks
duration.
2.surgeries involving implants eg: mesh in incisional hernias.
3.patients receiving chemotherapy ,radiotherapy, immunotherapy ,or
completed therapy with in last one month.
4.Hemodynamically un stable patients.
5.patients in sepsis.
6.patients with re-laparotomies.
7.patients who are allergic to silk products
8.patients who are included in other trials. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
wound healing time measured by dr. kamal
adaptive wound healing score |
wound healing time measured by dr. kamal
adaptive wound healing score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.amount of wound exudate by weighing soaked
gauze pieces using digital scale.
2. length of hospital stay measured in days.
3.Scar characteristics assessed by vancouver
scar scale |
3 months |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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 2 |
|
Date of First Enrollment (India)
|
27/02/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhanucprakash1@gmail.com].
- For how long will this data be available start date provided 24-02-2024 and end date provided 27-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
EFFECTIVENESS OF SILK FIBROIN DRESSING IN POST LAPAROTOMY PATIENTS SUPERFICIAL SURGICAL SITE INFECTIONS COMPARED TO SALINE DRESSING IN WOUND HEALING.
PRIMARY PURPOSE : To compare the effectiveness of silk fibroin dressing and normal saline dressing in wound healing time measured by kamal’s adaptive wound healing score. BRIEF STUDY HYPOTHESIS : SSI is defined as the infection that occurs within 30 days of operative procedure or within a year of implant placement if implant is placed and the infection is thought to be secondary to surgery. Negative pressure dressing is a new technique in treating ssi. Likewise silk fibroin is also emerging methods of treating SSI, proven in some studies as an effective method to reduce wound healing time and complications that arise due to SSI. Silk-based biomaterials stand out for its versatility and natural biocompatibility. They are available as many formats i.e., mats, sheets,foam,gel, powder. Silk biomaterials have been applied, e.g., in bone, cartilage, muscular tissue. Control of the biodegradation rate of the silk hydrogel and its high bioactivity makes this biomaterial a choice for soft tissue engineering in comparison to other hydrogel-based formulations, such as polydimethylsiloxane (PDMS) and agarose(8), that show a negligible degradation due to the lack, in mammalian tissues, of enzymes able to decompose such materials . A randomized clinical trial proved that applying silk fibroin decreases both wound healing time and adverse effects compared to other commercial dressings. i.e.,100 % healed by 14 days,and 88.6 % with controlled wound dressing improved in 19 days. In this study I would like to test efficacy of silk fibroin in regeneration of soft tissue and wound healing in SSI developed in laparotomy patients |