| CTRI Number |
CTRI/2026/01/102418 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of skin graft healing after harvesting with and without tumescent techniques. |
|
Scientific Title of Study
|
A Comparitive Study of Split Thickness Skin Graft Take Following Harvesting With Tumescent Technique versus Non-Tumescent Technique. |
| 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 ARUL D C |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem |
| Address |
Department of General Surgery
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9787112345 |
| Fax |
|
| Email |
draruldc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr EMJ KARTHIKEYAN |
| Designation |
Professor |
| Affiliation |
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem |
| Address |
Department of General Surgery
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9842256564 |
| Fax |
|
| Email |
emjkarthik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARUL D C |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem |
| Address |
Department of General Surgery
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9787112345 |
| Fax |
|
| Email |
draruldc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR ARUL D C |
| Address |
Department of General Surgery
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem |
| Type of Sponsor |
Other [Self] |
|
|
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 ARUL D C |
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem |
Department of General Surgery
Vinayaka Mission’s Kirupananda Variyar Medical College, Salem
Salem
TAMIL NADU |
9787112345
draruldc@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: V239||Unspecified motorcycle rider injured in collision with car, pick-up truck or van in traffic accident, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Patients aged 18–65 years.
Indicated for split-thickness skin grafting due to trauma, burns, or post- excisional defects.
Hemodynamically stable.
Willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Known allergy to lignocaine or epinephrine.
Coagulopathies or on anticoagulation therapy.
Active infection at the donor or recipient site.
Uncontrolled diabetes or peripheral vascular disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of graft take assessed clinically on postoperative day 5 in patients undergoing split-thickness skin graft harvesting using tumescent versus non-tumescent technique. |
Percentage of graft take assessed clinically on postoperative day 5 in patients undergoing split-thickness skin graft harvesting using tumescent versus non-tumescent technique. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative blood loss measured during split-thickness skin graft harvesting in both groups.
•
• Postoperative pain at the donor site assessed using Visual Analog Scale (VAS) on postoperative days 1, 2, and 3
•
• Percentage of donor site epithelialization assessed on postoperative day 10.
•
• Incidence of postoperative complications including hematoma, seroma, and infection at donor and recipient sites during the postoperative follow-up period of 3 week
•
• Final clinical outcome of graft and donor sites assessed at 3 weeks postoperatively.
|
18 weeks |
|
|
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)
|
14/07/2027 |
| 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
|
This study aims to compare the outcomes of split-thickness skin grafts (SSG) harvested using the tumescent technique versus the conventional non-tumescent method. The objective is to evaluate differences in graft take, donor site healing, intraoperative blood loss, postoperative pain, and overall patient satisfaction. In the tumescent technique, a diluted local anesthetic with adrenaline is infiltrated into the donor site, providing hydrodissection, hemostasis, and analgesia. In contrast, the non-tumescent method involves direct graft harvesting without prior infiltration. The study includes patients undergoing skin grafting for various wounds, divided into two groups based on the technique used. Parameters such as graft survival rate, incidence of hematoma or infection, donor site complications, and ease of graft harvest are analyzed and compared. Preliminary results suggest that the tumescent technique offers advantages, including reduced intraoperative bleeding, easier harvesting, and improved graft take, while ensuring better postoperative comfort. |