| CTRI Number |
CTRI/2025/07/091415 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Wound dressing] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the efficacy and safety of negative pressure dressing for non healing chronic ulcers |
|
Scientific Title of Study
|
Exploring the effectiveness of Vacuum-Assisted Closure (VAC) therapy in dermatology: A single-arm prospective interventional study. |
| 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 Sushnitha Johnson |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belgaum |
| Address |
Dept of Dermatology Venerology and Leprosy, Jawaharlal Nehru Medical College,
Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
9585222974 |
| Fax |
|
| Email |
sushnitha910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana R Doshi |
| Designation |
Head of department |
| Affiliation |
Jawaharlal Nehru Medical College, Belgaum |
| Address |
Dept of Dermatology Venerology and Leprosy, Jawaharlal Nehru Medical College,
Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
9422306523 |
| Fax |
|
| Email |
bhavs1982@amail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushnitha Johnson |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belgaum |
| Address |
Dept of Dermatology Venerology and Leprosy, Jawaharlal Nehru Medical College,
Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
9585222974 |
| Fax |
|
| Email |
sushnitha910@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr E Sushnitha Johnson |
| Address |
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical
College. |
| 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 E Sushnitha Johnson |
KLEs Dr Prabhakar Kore hospital |
Opd no 23, 1st floor Dept of
Dermatology Venerology and Leprosy,
Jawaharlal Nehru Medical College.
Belgaum
KARNATAKA |
9585222974
sushnitha910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A30||Leprosy [Hansens disease], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Vacuum-Assisted Closure (VAC) therapy |
The wound is first debrided and irrigated with normal saline, ensuring adequate hemostasis, and the peri-wound skin is dried. A sterile foam dressing is applied to evenly distribute negative pressure across the entire wound bed. A Ryle’s tube is placed within the foam and connected to a vacuum pump via suction tube.
The wound is then sealed with an adhesive drape, covering the foam, tubing, and extending 3–5 cm beyond the wound margins to ensure a watertight and airtight seal.
This is followed by gamjee dressing and crepe bandage application.
The dressing is typically changed on the third day.
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All chronic ulcers including diabetic foot ulcers, venous ulcers, pyoderma gangrenosum ulcer, livedoid vasculopathy ulcer, vasculitis ulcer, infectious ulcer, traumatic ulcer, trophic ulcers.
Ulcers resistant to moist wound dressing, PRP, PRF dressing.
|
|
| ExclusionCriteria |
| Details |
Malignant ulcer.
Presence of necrotic tissue.
Pregnant or lactating women.
Actively bleeding ulcer.
Ulcers with underlying osteomyelitis.
Patients with bleeding/ coagulation disorder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Vacuum-Assisted Closure (VAC) therapy in the management of chronic ulcers. |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of Vacuum-Assisted Closure (VAC) therapy in the management of chronic ulcers. |
one year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/08/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
After screening, all patients with chronic ulcer will be chosen. Before starting treatment, detailed history, clinical examination of patients will be done. The patient will be informed about the treatment given and need for hospital stay during the procedure. Informed written consent will be taken from each patient. Data will be collected by a single examiner and recorded in case proforma. Pus culture was taken from the wound prior to the start of dressing. The wound is first debrided and irrigated with normal saline, ensuring adequate hemostasis, and the peri-wound skin is dried. A sterile foam dressing is applied to evenly distribute negative pressure across the entire wound bed. A Ryle’s tube is placed within the foam and connected to a vacuum pump via suction tube. The wound is then sealed with an adhesive drape, covering the foam, tubing, and extending 3–5 cm beyond the wound margins to ensure a watertight and airtight seal. This is followed by gamjee dressing and crepe bandage application. The dressing is typically changed on the third day. The negative pressure is maintained at 75 to 125mmHg. Depending on the wound depth and size, number of vac dressing is decided to a maximum of 4 weeks. Later the patient was followed up with betadine dressing. After 4 weeks, digital photographs will be taken and compared with the baseline. The efficacy of VAC therapy will be assessed by improvement in wound area, circumference, length, width, microbial clearance and presence of granulation tissue. This measurement will be made by imitoMeasureTM app, granulation tissue presence will be assessed using visual photographs and microbial clearance by culture reports. Patient’s assessment of improvement will be recorded by visual analogue scale. The safety of VAC therapy will be assessed by the side effects associated with the therapy. |