A Study to Find the Better Way to Improve Skin Graft Healing After Surgery

Split thickness graft integration post Tumescent VS Non Tumescent harvesting methodologies-A Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087112

Enrollment

Registered

2025-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: Z428- Encounter for other plastic and reconstructive surgery following medical procedure or healed injury Health Condition 2: Z428- Encounter for other plastic and reconstructive surgery following medical procedure or healed injury Health Condition 3: O- Medical and Surgical

Interventions

Intervention1: Tumescent Technique with Hyaluronidase: Intervention Agent: Tumescent Technique (TT) with Hyaluronidase Composition: Lidocaine: 0.05% 0.1% Adrenaline (Epinephrine): 1:500,000 to 1:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-65 years with no immunocompromised status and who gave consent to participate in the study. 2. Patients with clean wounds prepared for grafting.

Exclusion criteria

Exclusion criteria: 1. Patients who are Immunocompromised - HIV and AIDS 2. Patient with albumin levels less than 30 gram per deciLitre, Haemoglobin level less than 10 gram per deciLitre 3. Patients who refused or were unable to give consent. 4. Patient with known allergy to adrenaline. 5. Pus swab positive for any significant growth of organisms. 6. Patients who were currently smoking and had stopped smoking less than six months.

Design outcomes

Primary

Measure	Time frame
To assess and compare the graft take-up rate between split thickness skin grafting methodologies tumescent vs non tumescent techniques utilizing tumescent and non-tumescent methodologies.Timepoint: To assess and compare the graft take-up rate between split thickness skin grafting methodologies on post operative days 5, 10, 21 techniques utilizing tumescent and non-tumescent methodologies.	—

Secondary

Measure	Time frame
Safety & Complications (Infection, Hematoma, Delayed Healing, Graft Failure) Day 5, Day 10, & Day 21 2. Feasibility & Cost-Effectiveness Throughout the Study (Final analysis after Day 21)Timepoint: Secondary Outcomes & Time Points: Safety & Complications (Infection, Hematoma, Delayed Healing, Graft Failure) Day 5, Day 10, & Day 21 Feasibility & Cost-Effectiveness Throughout the Study (Final analysis after Day 21)	—

Measure

Time frame

Safety & Complications (Infection, Hematoma, Delayed Healing, Graft Failure) Day 5, Day 10, & Day 21 2. Feasibility & Cost-Effectiveness Throughout the Study (Final analysis after Day 21)Timepoint: Secondary Outcomes & Time Points: Safety & Complications (Infection, Hematoma, Delayed Healing, Graft Failure) Day 5, Day 10, & Day 21 Feasibility & Cost-Effectiveness Throughout the Study (Final analysis after Day 21)

—

Countries

India

Contacts

Public ContactASHWYN ANAND NELSON

Aarupadai veedu medical college and Hospital

skdrsampathkumar@gmail.com9486267863

Outcome results

None listed

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