| CTRI Number |
CTRI/2026/01/100524 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study comparing collagen sheets in study group and paraffin dressings in control group for donor site dressing in patients with extensive skin graft harvest . |
|
Scientific Title of Study
|
A study comparing collagen sheets and paraffin dressings for donor site dressing-A randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDeepti Katrolia |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 403, 4th floor OPD Building AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8587997469 |
| Fax |
|
| Email |
deepti.katrolia@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDeepti Katrolia |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 403 ,4th floor ,OPD Building AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8587997469 |
| Fax |
|
| Email |
deepti.katrolia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDeepti Katrolia |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 403 ,4th floor,OPD Building AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8587997469 |
| Fax |
|
| Email |
deepti.katrolia@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Basni industrial area phase II 342005 |
| 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 |
| DrDeepti Katrolia |
AIIMS Jodhpur |
Department of Burns and Plastic Surgery,room no 403 ,4 th floor,OPD Building AIIMS Jodhpur
Jodhpur
RAJASTHAN |
8587997469
deepti.katrolia@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMSJ |
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 |
Collagen dressing |
Collagen dressing for the donor site to improve healing ,decrease infection and pruritus.The collagen dressing once applied will remain till 21 days . |
| Comparator Agent |
Paraffin dressing for control group for 21 days |
The comparator will be paraffin dressing for the control group .The paraffin dressing once applied will remain at the donor site for 21 days . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Donor site after skin graft harvest of size more than 20x10 cm
Post-infective,post-traumatic or surgically created wound
|
|
| ExclusionCriteria |
| Details |
1) Less than 18 years and more than 65 years.
2)Severe anaemia and Hypoproteinaemia
)Immunocompromised state
4) Uncontrolled Diabetes
5)Psychiatric conditions
6) Collagen vascular disease
7)The patient is on systemic steroids. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing time of donor sites in both the groups at 21 days
Pain control in both the groups at 21 days |
Healing time of donor sites in both the groups at 21 days
Pain control in both the groups at 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the post-healing scar in both groups.
2) To assess the pruritus in both groups.
3 ) To assess the soakage of the dressing in both groups.
4) To assess the patient satisfaction scores in both groups. |
1) 21 and 35 days
2)21 days
3) initial 5 days daily
4)21 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/02/2026 |
| 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="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 - NO
|
|
Brief Summary
|
This trial will be done in patients with excessive skin graft harvest of size more than 20x10 cm .In study group collagen sheet would be applied and in control group paraffin dressing would be applied . Assessment of healing and pain would be assessed as primary objective. Pruritus,soakage,scar and patient satisfaction would be done as secondary objectives. |