| CTRI Number |
CTRI/2024/09/074061 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study to comapre two groups |
| Study Design |
Other |
|
Public Title of Study
|
To compare graft take and graft quality between split-thickness skin graft alone and split-thickness skin graft over acellular dermal matrix in a surgically created wound |
|
Scientific Title of Study
|
A prospective study to compare immediate application of split-thickness skin graft over acellular dermal matrix with split-thickness skin graft alone in surgically created wounds |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ananay Vishvakarma |
| Designation |
MCh Resident 1st year |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Plastic and Reconstructive Surgery ESIC Medical College and Hospital Faridabad Haryana
Faridabad
HARYANA
121001
India |
| Phone |
9635152483 |
| Fax |
|
| Email |
ananayv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhupender Singh |
| Designation |
Professor |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Plastic and Reconstructive Surgery ESIC Medical College and Hospital Faridabad Haryana
Faridabad
HARYANA
121001
India |
| Phone |
7065867584 |
| Fax |
|
| Email |
bhupimch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ananay Vishvakarma |
| Designation |
MCh Resident 1st year |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Plastic and Reconstructive Surgery ESIC Medical College and Hospital Faridabad Haryana
Faridabad
HARYANA
121001
India |
| Phone |
9635152483 |
| Fax |
|
| Email |
ananayv@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, NIT, Faridabad - 121001 (Haryana) India
Phone No. 0129-2985080 |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital |
| Address |
NIT, Faridabad - 121001 (Haryana) India
Phone no. 0129-2985080 |
| 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 |
| Dr Ananay Vishvakarma |
ESIC Medical College and Hospital |
Department of Plastic and Reconstructive Surgery
OPD Room No. 3010
Plastic Surgery Ward 9th floor
Faridabad
HARYANA |
9635152483
ananayv@gmail.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 |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Split-thickness skin graft over acellular dermal matrix vs split-thickness skin graft alone |
I will be comparing outcomes following single stage grafting of
acellular dermal matrix of 1 mm thickness and split-thickness skin graft with
split-thickness skin graft alone in surgically created wounds |
| Comparator Agent |
To compare graft take and graft quality in terms of skin pigmentation and pliability |
I will be comparing outcomes following single stage grafting of acellular dermal matrix of 1 mm thickness and split-thickness skin graft with split-thickness skin graft alone in surgically created wounds |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age more than 10 years and of either sex.
Wound size (20cm square – 150cm square) |
|
| ExclusionCriteria |
| Details |
Uncontrolled diabetes mellitus
Peripheral Vascular disease
Burn wounds |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the percentage of graft take |
At postoperative Day 5 and Day 10. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of skin graft in terms of pigmentation and pliability. |
At 8 weeks postoperatively |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
28/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, we will be comparing outcomes following single stage grafting of acellular dermal matrix of 1mm thickness and split-thickness skin graft with split-thickness skin graft alone in surgically created wounds. The outcomes will be assessed on day 5 and day 10 postoperatively for percentage of graft take, and at 8 weeks postoperatively to assess the quality of graft in terms of skin pigmentation and pliability. |