| CTRI Number |
CTRI/2025/08/093814 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Spray Gun Technique for Skin Grafting on Post-Traumatic Wounds: A Pilot Study |
|
Scientific Title of Study
|
Skin Graft Harvesting and Application by indigenously developed Spray Gun technique on Post Traumatic Raw areas: A Pilot study |
| 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 Sushma Sagar |
| Designation |
Professor |
| Affiliation |
JPNATC AIIMS |
| Address |
Room 229 second floor Division of Trauma Surgery and Critical Care
JPNATC AIIMS
New Delhi DELHI 110029 India |
| Phone |
9868397702 |
| Fax |
|
| Email |
sagar.sushma@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sushma Sagar |
| Designation |
Professor |
| Affiliation |
JPNATC AIIMS |
| Address |
Room 229 second floor Division of Trauma Surgery and Critical Care
JPNATC AIIMS
New Delhi DELHI 110029 India |
| Phone |
9868397702 |
| Fax |
|
| Email |
sagar.sushma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sushma Sagar |
| Designation |
Professor |
| Affiliation |
JPNATC AIIMS |
| Address |
Room 229 second floor Division of Trauma Surgery and Critical Care
JPNATC AIIMS
New Delhi DELHI 110029 India |
| Phone |
9868397702 |
| Fax |
|
| Email |
sagar.sushma@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
Pacify Medical Technologies Pvt. Ltd. It is certified under ISO 13485:2016. |
|
|
Primary Sponsor
|
| Name |
Pacify Medical Technologies Private Limited |
| Address |
6007, Rahul Bajaj TechnologyInnovation centre, IIT Bombay Academic area, YP Road, Powai, Mumbai-400076, Maharashtra, India |
| Type of Sponsor |
Other [Private company] |
|
|
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 |
| Prof Sushma Sagar |
JPN APEX TRAUMA CENTRE |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES New Delhi South DELHI |
011 26731118
sagar.sushma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Submittted/Under Review |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T798||Other early complications of trauma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intra subject control |
Patient will be their own controls |
| Intervention |
Spray Gun |
Minced Micrograft using spray gun for management of raw areas following trauma for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who are hospitalized and in whom Split thickness skin graft is harvested
2 Patients presenting exclusively with traumatic wounds. |
|
| ExclusionCriteria |
| Details |
1 Critically ill patients
2 Presence of skin disease at the time of enrolment
3 Treatment with immunosuppressants
4 Pregnant/lactating women
5 Concurrent participation in other studies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a Spray-to-Donor Area Ratio: Ratio of the sprayed area to the harvested donor skin area applied to the wound site.
b Graft Take Rate: Percentage of graft uptake, defined as the ratio of epithelialized graft area to the total grafted area, assessed on postoperative Day 10
c Epithelialized Area: Measurement of the area of epithelialization on Days 5, 7, and 10 postoperatively.
d Percentage of Epithelialization: Quantification of epithelialization on Day 10 using imaging software, expressed as a percentage of the initial wound area
|
Follow up at day 3,day 5, day7,day10, day14 and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a Incidence of Infection/Discharge: Presence of infection or wound discharge up to Day 10 or until patient discharge, whichever occurs earlier.
b Delayed Healing Due to Complications: Occurrence of delayed wound healing attributable to any complications observed up to Day 10 or until discharge.
c Frequency of Dressing Changes: Total number of dressing applications required up to Day 10 or until discharge.
|
Follow up at day 3,day 5, day7,day10, day14 and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
08/09/2025 |
| 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="0" 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 prospective, interventional pilot study will investigate the
effectiveness of spray gun-assisted autologous skin grafting in accelerating
healing in traumatic wounds. With the increasing burden of complex traumatic
injuries in low-resource settings, there will be a pressing need to enhance
wound healing outcomes while minimizing donor site morbidity. The spray gun
method will allow uniform distribution of minced skin grafts, enabling
significant expansion of donor skin and promoting early epithelialization. The
study will be conducted at AIIMS Trauma Centre and will enroll 30 adult
patients who will meet the inclusion criteria for split-thickness skin grafting
(STSG). Each patient will serve as their own control. One half of the STSG
donor site will be treated with the spray technique, while the other half will
receive standard care. The primary endpoints will include graft take
percentage, degree and rate of epithelialization, and pain assessment.
Secondary parameters will include infection rates, dressing frequency, and
analgesic requirements. |