| CTRI Number |
CTRI/2025/10/096503 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the outcome of Epidermal growth factor dressing in comparison to Collagen sheet dressing for Skin graft donor site wound healing |
|
Scientific Title of Study
|
Epidermal growth factor dressing in comparison to Collagen sheet dressing for Skin graft donor site wound |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amirtharaj N |
| Designation |
Post graduate in general surgery |
| Affiliation |
Aarupadai veedu medical college |
| Address |
C block, Department of General Surgery, Aarupadai Veedu Medical College, Kirumampakkam, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
6382317710 |
| Fax |
|
| Email |
nsurya274@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravichandran K |
| Designation |
Professor |
| Affiliation |
Aarupadai veedu medical college |
| Address |
Room no. 10,C block, Department of General Surgery, Aarupadai Veedu Medical College, Kirumampakkam, Puducherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
6382317710 |
| Fax |
|
| Email |
drkravichandranyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amirtharaj N |
| Designation |
Post graduate in general surgery |
| Affiliation |
Aarupadai veedu medical college |
| Address |
C block, Department of General Surgery, Aarupadai Veedu Medical College, Kirumampakkam, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
6382317710 |
| Fax |
|
| Email |
nsurya274@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college, Kirumampakkam, Pondicherry 607402, India |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical college |
| Address |
C block, Department of General Surgery, Kirumampakkam, Pondicherry |
| 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 Amirtharaj N |
Aarupadai veedu medical college |
Room no 10, C block, Department of general surgery, Aarupadai veedu medical college and hospital, Kirumampakkam, Pondicherry
Pondicherry
PONDICHERRY |
6382317710
avmc.surg@edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Collagen sheets |
Collagen sheet dressing over skin graft donor site wound |
| Intervention |
Epidermal growth factor |
Epidermal growth factor local applicant is applied over skin graft donor site wound |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing split thickness skin grafting were included in the study |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to collagen
Infected donor site wound
Uncontrolled diabetes
Severe anemia and Hypoproteinemia
Immunocompromised patients
Mentally ill patients
Malignancy, local irradiation
Collagen vascular disease
Patient refusal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Epidermal growth factor dressing is better than Collagen sheet dressing in aspects of Wound healing time, Scar quality, Low chance of Surgical site infection.
But, Collagen sheet dressing is better in terms of Pain in comparison with Epidermal growth factor local applicantion. |
Assessing donor site wound on post operative day 14 and 21 for wound characteristics |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain over donor site wound on comparing epidermal growth factor and collagen sheet dressing |
Post operative day 2, 4,6 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
07/11/2025 |
| 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="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 - NO
|
|
Brief Summary
|
After the clearance from the IRC and IEC, sampling of patients for Epidermal Growth Factor and Collagen sheet dressing done by Group Allocation concealment method during the study period mentioned, fulfilling the inclusion and exclusion criteria already listed above will be recruited for the study, after obtaining informed consent. The nature, purpose, and the roles in the study will be explained in detailed, including the information that their non-participation in the study would not affect the quality of the treatment that they are to receive and that they are free exit the study at any time. After assuring that their response would remain confidential, an informed written consent for the same shall be obtained from the all participants. Patients will be randomized into two groups. This is done by Group Allocation Concealment Method (i.e) Patient has been separated randomly into two groups by single blinding technique as the investigator alone knows which patient is in which group. Collagen sheet dressing and Epidermal Growth Factor dressing will be performed for both the groups. In one group Collagen sheet dressing and in the other group Epidermal Growth Factor dressing will be performed. Duration of wound healing, post operative complications has been evaluated. Donor site dressing will be opened only after 14 days of surgery. On Post operative day 2, 4 and 6 , I will measure pain of the patients using Pain score scale. On Post operative day 14, 1 st look of the donor site wound will be done and 2 nd look will be done on post op day 21 based on scar pigmentation (Normal /Hypopigmentation /Hyperpigmentation), scab formation, infection.
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