| CTRI Number |
CTRI/2024/02/063283 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
Scars of artificial dermal template versus skin grafting for deep burn wounds |
|
Scientific Title of Study
|
Outcome analysis of split thickness skin grafting with Dermal regeneration template (Integra) versus Direct split thickness skin grafting for reconstruction of full thickness burn wounds. A prospective, open-labelled pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jalaz Joezer Rahmi |
| Designation |
Senior Resident (Academic) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR |
| Address |
DEPARTMENT OF BURNS AND PLASTIC SURGERY ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR
D-402 JAINAM PLANET TATIBANDH NEARS AIIMS HOSPITAL RAIPUR - 492099 CHATTISGARH
Raipur
CHHATTISGARH
492099
India |
| Phone |
8527017075 |
| Fax |
|
| Email |
jalaz_rahmi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jiten Kumar Mishra |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR |
| Address |
DEPARTMENT OF BURNS AND PLASTIC SURGERY ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR
CHHATTISGARH
492099
India |
| Phone |
8527017075 |
| Fax |
|
| Email |
mishra.jitenkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JALAZ JOEZER RAHMI |
| Designation |
SENIOR RESIDENT (ACADEMIC) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR |
| Address |
DEPARTMENT OF BURNS AND PLASTIC SURGERY ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR
CHHATTISGARH
492099
India |
| Phone |
8527017075 |
| Fax |
|
| Email |
jalaz_rahmi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Burns and Plastic Surgery All India Institute of Medical Sciences Raipur |
|
|
Primary Sponsor
|
| Name |
Department of Burns and Plastic Surgery |
| Address |
All India Institute of Medical Sciences Raipur Chattisgarh |
| 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 |
| JALAZ JOEZER RAHMI |
All India Institute of Medical Sciences Raipur |
Department of Burns and Plastic Surgery
Raipur
CHHATTISGARH |
8527017075
jalaz_rahmi@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X088||Exposure to other specified smoke,fire and flames, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTEGRA DERMAL REGENERATION TEMPLATE |
Dermal regeneration template is enclosed between two polyethylene sheets which need to be soaked in saline and removed. The bilayer template comprises of an outer silicone layer, and an inner layer made of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulphate) designed with controlled porosity and defined degradation rate to enable cellular infiltration and neovascularisation. The silicone layer provides immediate wound coverage and also prevents moisture loss from the wound and serves as a bacterial barrier. |
| Comparator Agent |
Split thickness skin grafting |
Direct split thickness skin grafting applied on deep dermal burn wounds |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with burns wounds presenting to the Department of Burns and Plastic Surgery All India Institute of Medical Sciences Raipur
Deep Second degree or third degree depth of burn wounds (Flame burns, scald burns, chemical burns) requiring skin grafting
Hemodynamically stable patients
Burn wounds with TBSA - minimum 250cm2
BURN WOUNDS WITH TBSA - MINIMUM 250CM2 |
|
| ExclusionCriteria |
| Details |
FIRST DEGREE BURNS WOUNDS OR SUPERFICIAL SECOND DEGREE BURN WOUNDS
EXTENSIVE BURNS IN PATIENTS WITH HEMODYNAMIC INSTABILITY
BURNS PATIENTS WITH INADEQUATE NUTRITIONAL STATUS
PATIENTS OR RELATIVES NOT GIVING INFORMED CONSENT |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scar maturation and assessment of scar after 6 months |
Wound healing at discharge and scar maturation and its assessment after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications till complete wound healing |
Baseline at surgery & complications within two weeks from surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/03/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title: Outcome analysis of split thickness skin grafting with Dermal regeneration template (Integra) versus direct split thickness skin grafting for reconstruction of full thickness burn wounds - a prospective, open labelled pilot study Research Question: Does application of split thickness skin grafting with a dermal regeneration template (Integra) lead to better scar formation as compared to direct split thickness skin grafting in full thickness burn wounds? Research Hypothesis: In full thickness burn wounds, application of split thickness skin grafting with dermal regeneration template (Integra) leads to better scar formation and lesser skin graft related complications as compared to direct split thickness skin grafting Aim: To assess the advantage of split thickness skin grafting with a dermal regeneration template (Integra) over conventional split thickness skin grafting for reconstruction of full thickness burn wounds Primary objective: To compare outcomes of split thickness skin grafting with Dermal regeneration template (Integra) versus direct split thickness skin grafting in terms of : Maturation of scar at 6 months (according to clinical classification International advisory panel on scar management) and assessment of scar at 6 months (by Hamilton burn scar scale) Secondary objective: assessment of complications (seroma, hematoma, infection, graft loss) and secondary procedures required (repeat grafting) Study design: Prospective, open labelled pilot study Duration: 18 months after ethical clearance
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