| CTRI Number |
CTRI/2025/12/099052 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective comparative |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in patients with wounds to see whether vacuum-assisted (suction) dressing helps wounds heal faster and improves skin graft success compared to regular dressings. |
|
Scientific Title of Study
|
To evaluate the efficacy of Vaccum assisted closure therapy as a pretreatment modality for split thickness skin grafts |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shravani Jawadi |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Education and Research (JNMC, Wardha) |
| Address |
Department Of Surgery
Jawaharlal Nehru Medical College
Sawangi (Meghe)
Wardha
Maharashtra 442001
Department Of Surgery
Jawaharlal Nehru Medical College
Sawangi (Meghe)
Wardha
Maharashtra 442001
Nagpur
MAHARASHTRA
442001
India |
| Phone |
8788237932 |
| Fax |
|
| Email |
crazyamygdala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venktesh Rewale |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Education and Research (JNMC, Wardha) |
| Address |
Department Of Surgery
Jawaharlal Nehru Medical College
Sawangi (Meghe)
Wardha
Maharashtra 442001
Department Of Surgery
Jawaharlal Nehru Medical College
Sawangi (Meghe)
Wardha
Maharashtra 442001
Nagpur
MAHARASHTRA
442001
India |
| Phone |
8007887196 |
| Fax |
|
| Email |
drvmrewale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shravani Jawadi |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Education and Research (JNMC, Wardha) |
| Address |
Department Of Surgery
Jawaharlal Nehru Medical College
Sawangi (Meghe)
Wardha
Maharashtra 442001
Department Of Surgery
Jawaharlal Nehru Medical College
Sawangi (Meghe)
Wardha
Maharashtra 442001
Nagpur
MAHARASHTRA
442001
India |
| Phone |
8788237932 |
| Fax |
|
| Email |
crazyamygdala@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Medical Sciences |
| Address |
Department of Surgery
Sawangi (Meghe)
Wardha
Maharashtra - 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shravani Jawadi |
Acharya Vinoba Bhave Hospital |
Department Of Surgery
Sawangi (Meghe)
Wardha
Maharashtra 442001
Wardha
MAHARASHTRA |
8788237932
crazyamygdala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-70 years with acute or chronic wounds suitable for STSG.
Wounds with exposed granulation tissue and no exposed bone, tendon, or major vessels.
Patients willing to adhere to VAC therapy for the required pretreatment period.
Informed consent was obtained for participation in the study. |
|
| ExclusionCriteria |
| Details |
Patients with wounds involving significant necrosis or infection resistant to treatment.
The presence of exceedingly exposed bone, tendons, or major blood is not amenable to grafting.
Patients with underlying medical conditions impairing wound healing (e.g., uncontrolled diabetes, severe peripheral vascular disease).
Individuals on immunosuppressive therapy or with malignancies involving the wound area.
Pregnant or lactating women.
Patients with contraindications to VAC therapy, such as active bleeding disorders or inability to tolerate negative pressure.
All patients not consenting for study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Graft uptake percentage of the grafted area at postoperative 7-14, measured by standardized digital planimetry from calibrated wound photographs (unit:%) |
Postoperative day 7-14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
29/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 address these gaps by evaluating the efficacy of VAC therapy as a
pretreatment modality for STSG. Specifically, it will compare wound healing
time, infection control, graft take rates and patient satisfaction between VAC
therapy and conventional wound care. By doing so, this study seeks to provide a
clearer understanding of how VAC therapy influences outcomes in patients
undergoing STSG, contributing to evidence-based improvements in clinical
practice. |