| CTRI Number |
CTRI/2024/03/063447 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Modality- LASER] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of low level laser therapy, a non-invasive, low intensity LED for surgical scar following surgeries in the abdomen to promote scar healing and to reduce pain |
|
Scientific Title of Study
|
Effects of low level laser therapy on wound healing in obese abdominal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syed Shanaz FathimaA |
| Designation |
MPT student |
| Affiliation |
Sri Ramachandra Institute of Higher education and research |
| Address |
No.1, Sri Ramachandra Institute of Higher education and research, Porur, Chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
09566253691 |
| Fax |
|
| Email |
shanazfathima234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs.S.Sridevi |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher education and research |
| Address |
No. 1, Ramachandra Nagar, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841401565 |
| Fax |
|
| Email |
Devibsmoorthy@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Syed Shanaz FathimaA |
| Designation |
MPT student |
| Affiliation |
Sri Ramachandra Institute of Higher education and research |
| Address |
No. 1, Ramachandra Nagar, Sri Ramachandra Institute of higher education and research, Porur, Chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
09566253691 |
| Fax |
|
| Email |
shanazfathima234@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Syed Shanaz FathimaA |
| Address |
Sri Ramachandra Institute of Higher education and research |
| 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 Shanaz Fathima PT |
Sri RamSri Ramachandra Institute of Higher Education and Research |
2nd floor, Sri Ramachandra Faculty of physiotherapy
Chennai
TAMIL NADU |
9566253691
shanazfathima234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low level LASER therapy |
Low level LASER therapy
Duration: From post operative day 1 till the day of discharge (10th day)
Every alternate days (day 1, 3,5,7) |
| Comparator Agent |
Routine care |
Routine surgical scar care
Duration: From day 1 till the day of discharge) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective abdominal surgery
consented patients |
|
| ExclusionCriteria |
| Details |
1.Postoperative hemodynamic instability
2.Pregnancy
3. History of epilepsy/seizures
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS for pain, POSAS, photographs of the scar |
Post operative day 1 and post operative day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS for pain |
1 week after the laser session |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2024 |
| 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="0"
Months="2"
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
|
Low level LASER therapy enhances and accelerates the process of wound healing. hence, in this study, obese patients are recruited to administer LASER as the wound healing process is delayed in these population in comparison to individuals with normal built. Both the genders of age 25-60 are recruited with sample size of 30. The interventional group is given low level laser therapy while the control group is given the routine care. Baseline data of VAS for pain and the photographs of the scar is used. The treatment is given during every alternate days from day 1 till day 10 of their hospital stay. |