| CTRI Number |
CTRI/2020/11/029410 [Registered on: 26/11/2020] Trial Registered Prospectively |
| Last Modified On: |
29/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare negative pressure wound therapy with classical on traumatic wounds |
|
Scientific Title of Study
|
Comparative study of negative pressure wound therapy versus conventional dressing for the management of traumatic wound |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshit agrawal |
| Designation |
Junior resident 2 |
| Affiliation |
Institute of medical sciences ,bhu varanasi |
| Address |
Room 345 Sushruta hostel trauma centre bhu, varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7380583352 |
| Fax |
|
| Email |
akshitagrawal.a1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akshit agrawal |
| Designation |
Junior resident 2 |
| Affiliation |
Institute of medical sciences ,bhu varanasi |
| Address |
Room 345 Sushruta hostel trauma centre bhu, varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7380583352 |
| Fax |
|
| Email |
akshitagrawal.a1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshit agrawal |
| Designation |
Junior resident 2 |
| Affiliation |
Institute of medical sciences ,bhu varanasi |
| Address |
Room 345 Sushruta hostel trauma centre bhu, varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7380583352 |
| Fax |
|
| Email |
akshitagrawal.a1@gmail.com |
|
|
Source of Monetary or Material Support
|
| institute of medical sciences,banaras hindu university varanasi |
|
|
Primary Sponsor
|
| Name |
Institute of medical sciencesBHU Varanasi |
| Address |
Institute of medical sciences ,BHU varanasi |
| Type of Sponsor |
Government medical college |
|
|
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 shashi prakash mishra |
Trauma Centre Institute of Medical Sciences BHU |
Institute of Medical Sciences BHU Varanasi
Varanasi
UTTAR PRADESH |
8318530597
spmishra.gs@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee institute medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S818||Open wound of lower leg, (2) ICD-10 Condition: S518||Open wound of forearm, (3) ICD-10 Condition: S411||Open wound of upper arm, (4) ICD-10 Condition: S711||Open wound of thigh, (5) ICD-10 Condition: S913||Open wound of foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional dressing |
serial debridement and saline wash of the wound is done and the conventional gauge dressing is applied untill wound bed preparation or untill 6 weeks |
| Intervention |
negative pressure wound therapy |
negative pressure is applied on the wound using foam dressing which is connected either to the wall suction or a suction machine and follow up till the wound bed preparation or untill 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) patients giving consent for negative pressure therapy
2) clinically stable patients with traumatic wounds irrespective of mode or mechanism of trauma
3) patients of 10-70 years of age and either sex |
|
| ExclusionCriteria |
| Details |
1) refusal of consent
2) traumatic wounds with unmanaged underlying bony fracture
3) wounds with untreated underlying osteomyelitis
4) wounds with fistulas to organs or body cavity
5) severe anemia
6) wounds with associated malignancy
7) dry gangrene
8) patients with chronic conditions like:-
a) uncontrolled diabetes mellitus
b) peripheral vascular disease
c) chronic venous insufficiency |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Changes in wound size
2)change in percentage of granulation tissue
3)change in bacteria colony count |
Every 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) changes in blood counts |
1 yr |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/12/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the study of Comparative study of negative pressure wound therapy versus conventional dressing for the management of traumatic wound going to be conducted in trauma centre in IMS,BHU in which 100 patients will be recruited ,50 in each limb.Patients in Each group will be allocated by computer generated random allocation and each group will be assessed on every 5th day for the comparision. Comparision will be done on following points1) change in wound size.
2) percentage of the granulation tissue formed
3) change in the bacterial colony count.
End point of the study is to prepare the wound bed for either split thickness skin grafting or by primary closure. |