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A proof of concept study to check how safe and effective it is to use a spray gun to apply donor skin on the wound site

A pilot observational study to evaluate the safety and efficacy in delivery of the donor skin segment using spray gun on the donor site - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/078890
Enrollment
30
Registered
2025-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: SKin spray device: Apply donor skin to raw wound using skin spray device just once at the time of enrolment for a time period enough to cut the donor skin into small segements Control I

Sponsors

Kasturba Medical College Manipal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults 18 years and above, any sex, willing to provide a written informed consent. [Women must be of no child-bearing potential or must have tested Negative for UPT] Female participants can be considered not of childbearing potential only if they are with current bilateral tubal ligation or occlusion, or post-hysterectomy, or post-bilateral ovariectomy, or post-menopause. 2. Patients who are hospitalized and in whom Split thickness skin graft is harvested 3. The participant/ Legally acceptable representative is willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who are critically ill 2. Documented skin disease at the time of enrollment as judged by the investigator 3. Treatment with immunosuppressants 4. Women who are pregnant or breast feeding 5. Inclusion in other ongoing study at present that would preclude the subject from participating in this study as judged by the investigator 6. Any other pathology that in the investigators opinion might interfere with the current study

Design outcomes

Primary

MeasureTime frame
a.Spray area to the harvested donor area ratio on the donor site b.Area of epithelialization c.Percentage of epithelialization measured with imaging software in order to compare with the initial wound area. Timepoint: Days 5 7 and 10

Secondary

MeasureTime frame
a. Incidence of infection/ Discharge b. Delay in healing due to complications c. Number of dressings d. Antiseptics, antibiotics and analgesics as well as skin-related medication doses required e. Adverse device effect and serious adverse device effect (Infection of the study site, Failure of the graft to grow, Pain and discomfort have already beenide ntified as anticipated effects in the Product Risk Management Record) Timepoint: Day 10;VAS Pain scoreTimepoint: Days 5 7 and 10

Countries

India

Contacts

Public ContactDr Jeffrey Pradeep Raj

Kasturba Medical College Manipal

jpraj.m07@gmail.com8095464464

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026