| CTRI Number |
CTRI/2025/10/095838 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing collagen bandages to regular bandages to see which one works better for healing the skin of donor site after a graft. |
|
Scientific Title of Study
|
EFFICACY OF COLLAGEN SHEET DRESSINGS VERSUS CONVENTIONAL DRESSINGS ON DONOR SITE IN CASES OF SPLIT SKIN GRAFTING |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranav Dalvi |
| Designation |
Junior resident, Dept of General Surgery |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, WARDHA |
| Address |
Department of General Surgery, 4th floor, SMSC Building, AVBRH Campus, Sawangi, Meghe, Wardha
JNMC, SAWANGI (MEGHE), WARDHA, MAHARASHTRA, 442005
Nagpur
MAHARASHTRA
442001
India |
| Phone |
9870202600 |
| Fax |
|
| Email |
doctorpranavdalvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshana Tote |
| Designation |
Professor, Dept of General Surgery |
| Affiliation |
JawaharLal Nehru Medical College DMIHER |
| Address |
Department of General Surgery, 4th floor, SMSC Building, AVBRH Campus, Sawangi, Meghe, Wardha
General Surgery Department, Jawaharlal Nehru Medical College,
DMIHER Sawangi Meghe Wardha
Wardha
Maharashtra
442005
INDIA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9870202600 |
| Fax |
|
| Email |
doctorpranavdalvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranav Dalvi |
| Designation |
Junior resident, Dept of General Surgery |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, WARDHA |
| Address |
Department of General Surgery, 4th floor, SMSC Building, AVBRH Campus, Sawangi, Meghe, Wardha
JNMC, SAWANGI (MEGHE), WARDHA, MAHARASHTRA, 442005
Nagpur
MAHARASHTRA
442001
India |
| Phone |
9870202600 |
| Fax |
|
| Email |
doctorpranavdalvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Meghe, Wardha, India
442002 |
| Type of Sponsor |
Private 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 Pranav Dalvi |
ACHARYA VINOBA BHAVE RURAL HOSPITAL, |
ACHARYA VINOBA BHAVE RURAL HOSPITAL, JAWAHARLAL NEHRU MEDICAL COLLEGE, DEPARTMENT OF GENERAL SURGERY, DMIHER, SAWANGI MEGHE, WARDHA, MAHARASHTRA
WARDHA
MAHARASHTRA
Wardha
MAHARASHTRA |
9870202600
doctorpranavdalvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Re-regd. No.: ECR/440/Inst/MH/2013/RR-2019 Sawangi (Meghe) Wardha-442107, Maharashtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L984||Non-pressure chronic ulcer of skin, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EFFICACY OF COLLAGEN SHEET DRESSINGS
VERSUS CONVENTIONAL DRESSINGS ON DONOR
SITE IN CASES OF SPLIT SKIN GRAFTING |
EFFICACY OF COLLAGEN SHEET DRESSINGS
VERSUS CONVENTIONAL DRESSINGS ON DONOR
SITE IN CASES OF SPLIT SKIN GRAFTING |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All patients above. 18 years of age undergoing Split Skin Grafting.
Patients willing to give written and informed consent and comply with follow-up
schedule. |
|
| ExclusionCriteria |
| Details |
Patients with Uncontrolled Diabetes Mellitus, Immunocompromised states, or
Collagen Vascular diseases.
Patients with a known allergy to collagen or collagen-based products.
Patients lost to follow-up or unwillingness to participate fully in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. TIME TAKEN FOR COMPLETE EPITHELIALIZATION
2. ASSESS PAIN LEVELS
3. INCIDENCE OF WOUND INFECTION
4. COSMETIC OPUTCOME
5. COST EFFECTIVENESS |
2 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/10/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
Split Skin Grafting (SSG) is a well-established surgical technique widely employed in the
management of acute burns, chronic wounds, traumatic injuries, and reconstructive
procedures. In this technique, a thin layer of skin typically consisting of the epidermis and a
portion of the dermis is harvested from a healthy donor site and transplanted to a recipient
wound bed. While the primary focus is often on the graft take at the recipient site, the
management of the donor site is equally important, as it constitutes a second wound that
can be a significant source of pain, infection risk, delayed healing, and scarring. To evaluate the efficacy of Collagen sheet dressings versus Conventional Dressings on
donor site in cases of Split Skin Grafting. |