| CTRI Number |
CTRI/2024/06/068403 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
hyperbaric oxygen therapy in laparostomy wounds A new alternative therapy for abdominal wound healing |
|
Scientific Title of Study
|
effect of hyperbaric oxygen therapy in terms of time duration taken for healing of laparostomy wounds A pilot 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 |
Krishna Rajakumar |
| Designation |
Junior resident academic |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of surgery , 6th floor , A block ,AIIMS Rishikesh
Room 230 , hostel 84 ,AIIMS Rishikesh , 249203 , Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8870306815 |
| Fax |
|
| Email |
krishnarajakumar000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Rajakumar |
| Designation |
Junior resident academic |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of surgery , 6th floor , A block ,AIIMS Rishikesh
Room no 230, hostel 84 ,AIIMS Rishikesh , 249203 , Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8870306815 |
| Fax |
|
| Email |
krishnarajakumar000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Rajakumar |
| Designation |
Junior resident academic |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of surgery , 6th floor , A block ,AIIMS Rishikesh
Room no 230, hostel 84 , aiims rishikesh , 249203, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8870306815 |
| Fax |
|
| Email |
krishnarajakumar000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
krishna raja kumar |
| Address |
Department of surgery , 6th floor , A block ,AIIMS Rishikesh, pin 249203 |
| 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 |
| DrKrishna raja kumar |
AIIMS Rishikesh |
Deparment of surgery ,unit 3 ,6th floor ,AIIMS Rishikesh
Veerbadra road , Rishikesh
Uttarakhand
Dehradun
UTTARANCHAL |
08870306815
krishnarajakumar000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS RISHIKESH ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HBOT |
Hyperbaric oxygen therapy will be given at 2 atmospheric pressure at 90 mins per cycle for total of 10 cycles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Clinically stable patients with laparostomy wound
Patients giving informed written consent
|
|
| ExclusionCriteria |
| Details |
Patients with severe heart failure and severe pulmonary disease
Patients with tympanic membrane defects
Patients with malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses time duration of healing of laparostomy wounds using HBOT. Till 4 weeks |
To asses time duration of healing of laparostomy wounds using HBOT weekly till 4 weeks , baseline , week 1 ,2,3,4weeks . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To asses effect of HBOT on 30 day mortality
To assess complications related to HBOT
to measure pretherapy & postherapy CONUT & APACHE 2 scores
To measure pretherapy & postherapy serum inflammatory markers CRP weekly till HBOT Completes |
weekly CRPH, weekly wound size measurement pre & postherapy CONUT & APACHE till 4 weeks. Baseline , week 1 ,2 ,3 ,4 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
12/09/2024 |
| Date of First Enrollment (Global) |
15/06/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
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
Modification(s)
|
It is a pg thesis for dr.krishna raja kumar ms general surgery batch july 2022 AIIMS Rishikesh, the sample size is complete and currently in process of thesis submission and publishing |