| CTRI Number |
CTRI/2024/08/071904 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to assess whether Negative Pressure Wound Therapy is better than Conventional Wound management in post operative abdominal wounds. |
|
Scientific Title of Study
|
Hospital based Interventional Study to compare Negative Pressure wound Therapy and Conventional Wound Therapy in Open Post-Operative Abdominal Wounds. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEBARAJ SHOME PURKAYASTHA |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
c/o Prof (Dr) Gautam Das.
Dept of General Surgery
5th Floor, Ronald Ross building
IPGMER & SSKM Hospital
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9615342162 |
| Fax |
|
| Email |
dspurkayastha@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GAUTAM DAS |
| Designation |
Professor and Visiting Surgeon |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Dept of General Surgery
5th Floor, Ronald Ross building
IPGMER & SSKM Hospital
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830580728 |
| Fax |
|
| Email |
gautamdas_dr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DEBARAJ SHOME PURKAYASTHA |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
c/o Prof (Dr) Gautam Das.
Dept of General Surgery
5th Floor, RONALD ROSS Building
IPGMER & SSKM Hospital
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9615342162 |
| Fax |
|
| Email |
dspurkayastha@icloud.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital,
Bhowanipore,
Kolkata,
West Bengal,
India
700020
|
|
|
Primary Sponsor
|
| Name |
Debaraj Shome Purkayastha |
| Address |
Department of General Surgery
5th Floor, Ronald Ross Building
IPGMER & SSKM Hospital
Bhowanipore
Kolkata
700020
West Bengal
India |
| 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 Debaraj Shome Purkayastha |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Department of General Surgery,
5th Floor,
Ronald Ross Building,
IPGMER and SSKM Hospital,
Bhowanipore,
Kolkata,
West Bengal
700020
Kolkata
WEST BENGAL |
9615342162
dspurkayastha@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T814||Infection following a procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Wound Therapy |
Dressing with Saline soaked sterile gauze, followed by povidone iodine soaked sterile gauze,
followed by sterile saline wash and dressing with moist and dry sterile gauze.
Done once daily, total duration of 10 days. |
| Intervention |
Negative Pressure Wound Therapy |
Continuous Mode of application, 125 mmHg suction pressure, changed every 5 days for 2 such applications,
total duration of treatment 10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Participant/Authorised Representative is willing and able to provide written informed consent.
2.Diagnosis of post-surgical subcutaneous abdominal wound healing impairment, i.e. with intact fascia.
3.Minimum wound size eligible for the application of the intervention, i.e. where NPWT is feasible (fixed at 10 sq. cm for this trial.) |
|
| ExclusionCriteria |
| Details |
1.Age less than 18years.
2.A patient unable or unwilling to sign the Informed Consent Form, or to have their legally authorised representative act as a surrogate.
3.A patient unable or unwilling to comply with the protocol and study-related requirements.
4.Presence of Fascial defect of abdomen.
5.Necrotic tissue with eschar present.
6.Enteric or other Fistulae if present, or discharge containing Enteric content.
7.Possibility of Malignancy in wound.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gross and Percentage Area Reduction of wound. |
Gross and Percentage Area Reduction of wound at Day 10 after 2 cycles of therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life assessment using Visual Analog Scale |
At Day 10 |
| Adverse events |
At every Dressing Change |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/08/2024 |
| Date of Study Completion (India) |
15/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a randomized, open label, parallel group, single- centre trial comparing the safety and efficacy of Negative Pressure Wound Therapy (at -125mmhg continiously for 5 days per cycle) and Conventional Wound Therapy once daily in 75 hospitalized patients with Post Operative Open Abdominal Wounds with intact fascial sheath, that will be conducted in a single tertiary care center in Eastern India. The primary outcome measure will be Gross and Percentage Area reduction of wound at Ten Days i.e. after two cycles of therapy. The secondary outcome will be Gross and Percentage Area reduction of wound at Five Days i.e. after single cycle of therapy. |