| CTRI Number |
CTRI/2025/08/092962 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development and Efficacy Testing of Variable Pressure
Flat Ultrathin Water Jet Device for Debridement and Dissection – an Interventional Study |
|
Scientific Title of Study
|
Development and Efficacy Testing of Variable Pressure
Flat Ultrathin Water Jet Device for Debridement and Dissection |
| 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 Subhasish Sarkar |
| Designation |
Assistant Professor |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
Department of General Surgery, College of Medicine and Sagore Dutta Hospital
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
9564524882 |
| Fax |
|
| Email |
s.sarkar735@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhasish Sarkar |
| Designation |
Assistant Professor |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
Department of General Surgery, College of Medicine and Sagore Dutta Hospital
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
9564524882 |
| Fax |
|
| Email |
s.sarkar735@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhasish Sarkar |
| Designation |
Assistant Professor |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
Department of General Surgery, College of Medicine and Sagore Dutta Hospital
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
9564524882 |
| Fax |
|
| Email |
s.sarkar735@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Reasearch |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Reasearch |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Subhasish Sarkar |
College of Medicine and Sagore Dutta Hospital |
578 B. T. Road, Kamarhati, Kolkata - 700058. Department of General Surgery OPD Room 2.
North Twentyfour Parganas
WEST BENGAL |
9564524882
s.sarkar735@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, CMSDH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L08||Infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional wound debridement |
Wound debridement using mechanical abrasion, irrigation using saline, and surgical debridement will be provided twice weekly till the appearance of red granulation tissue. |
| Intervention |
Hydrodebridement with saline spray |
Treatment will be provided twice weekly. Treatment will be continued till appearance of red granulation tissues. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients above 18 years of age, suffering from different types chronic (viz. diabetic foot ulcer), traumatic , and burn ulcers. |
|
| ExclusionCriteria |
| Details |
Moribund patients and ulcers complicated by lymphedema were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound healing time, wound healing rate. Reduction in wound SINBAD score. |
Baseline SINBAD score at the recruitment. Per week wound SINBAD score will be noted. Final score will be noted on wound closure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
6 months, 1 Year. |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2025 |
| 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)
|
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
|
Debridement and dissection are most important aspects of surgery. Most of the chronic non-healing ulcers are covered with necrotic materials and bio-films making them complicated to manage. Current practice is surgically removing the necrotic materials from the wounds using scalpel blades and scissors. The major complications of this procedure are significant amount of blood loss, time consuming, loss of healthy granulation tissues and remaining of residual sloughs in between clefts of the wounds. These lead to repetition of the procedure and delayed wound healing. To overcome these challenges we propose a variable pressure flat ultrathin water jet which will effectively remove the necrotic and dead tissues while preserve the healthy tissue and minimize the amount of blood loss during debridement. Variable pressure flat ultrathin water jet had never been tried before for debridement and dissection. Water jet can be effectively applied to the clefts of the wounds leading to complete removal of slough. Mostly the procedure can be completed very quickly with no requirement of anesthesia at all. Again the water jet debridement procedure can be repeated daily with minimum morbidity till healthy granulation tissue appears. Variable pressure flat ultrathin water jet can be effectively used for dissection. Optimum water jet pressure with precise dimension can effectively divide the intervening fat and loose areolar tissue leading to separation and visualization of vital structures during difficult surgeries such as axillary dissection and pancreatic necrosectomy. This method will avoid the potentially dangerous complications of sharp dissection using scissors or diathermy. The variable pressure flat ultrathin water jet will reduce the dissection time and aid in proper identification of different structures with minimum complications. |