| CTRI Number |
CTRI/2024/09/073955 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of vac dressing on healing of different types of ulcers |
|
Scientific Title of Study
|
Effects of vaccum assisted negative pressure dressing on healing of different types of ulcer |
| 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 Rosidul Sarkar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Surgery
Silchar Medical College and Hospital
Ghungoor
Silchar
Cachar
ASSAM
788014
India |
| Phone |
7577890729 |
| Fax |
|
| Email |
rosidulsrkr56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debabrata Singha |
| Designation |
Professor and Guide |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Surgery
Silchar Medical College and Hospital
Ghungoor
Silchar
Cachar
ASSAM
788014
India |
| Phone |
9435072017 |
| Fax |
|
| Email |
Debabrata.singha12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debabrata Singha |
| Designation |
Professor and Guide |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of Surgery
Silchar Medical College and Hospital
Ghungoor
Silchar
Cachar
ASSAM
788014
India |
| Phone |
9435072017 |
| Fax |
|
| Email |
Debabrata.singha12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery,
Silchar Medical College and Hospital,Ghungoor,Pin-788014,Cachar,Assam |
|
|
Primary Sponsor
|
| Name |
Dr.Rosidul Sarkar |
| Address |
Department of General Suegery,
Silchar Medical College and Hospital,
Ghungoor,Silchar,Pin-788014,Cachar,Assam |
| Type of Sponsor |
Other [Self] |
|
|
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 Rosidul Sarkar |
Silchar Medical College and Hospital |
Department of General Surgery,Silchar Medical College and Hospital,Ghungoor,Silchar,Pin-788014
Cachar
ASSAM |
7577890729
rosidulsrkr56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Silchar Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L899||Pressure ulcer of unspecified site, (2) ICD-10 Condition: L97||Non-pressure chronic ulcer of lower limb, not elsewhere classified, (3) ICD-10 Condition: L984||Non-pressure chronic ulcer of skin, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Vaccum assisted negative pressure wound dressing |
Single vaccum dressing is applied to any type of ulcer of size less than 10 cm for 5 days for 3 settings.
frequency- 3 settings
duration of 1 setting- 5 days
total duration- 15 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with ulcer size less than 10 cm |
|
| ExclusionCriteria |
| Details |
1.To exclude TB ulcer
2.To exclude malignant ulcer
3.Ulcers where VAC dressing cannot be applied properly
4.Ulcers present over joint
5.Large burn ulcer
6.Ulcers involving osteomyelitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Growth of granulation tissue |
Day 0
Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/09/2024 |
| 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) |
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
|
Non healing or delayed healing of ulcer is one of the most prevalent reasons for hospital admission particularly in older adults.Negative pressure wound therapy is a surgical procedure in which vaccum assisted drainage is utilised to extract out edema fluid from a wound and supplies blood,oxygen and other necessary substances required for wound healing.It is developed as an alternate to the standard form of wound management.It has indirect effect of decrease morbidity,mortality,cost lowering and early return to work.The study proposes demonstration of benefits and usage of VAC dressing in our set up. |