| CTRI Number |
CTRI/2024/05/066946 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predictions of wound infection in diabetics undergoing major amputation surgery |
|
Scientific Title of Study
|
Predictors of surgical site infection post lower extremity amputation in diabetic population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ridhi Dhadwaiwale |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of general surgery
Kasturba medical college and hospital, Manipal, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9406869839 |
| Fax |
|
| Email |
ridhidhadwaiwale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavan Madhukar Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of general surgery
Kasturba medical college and hospital, Manipal, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9731243720 |
| Fax |
|
| Email |
pavanbhat76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavan Madhukar Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of general surgery
Kasturba medical college and hospital, Manipal, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9731243720 |
| Fax |
|
| Email |
pavanbhat76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Ridhi Dhadwaiwale |
| Address |
Department of General Surgery
Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka, India, 576104 |
| Type of Sponsor |
Private 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 |
| Ridhi Dhadwaiwale |
Kasturba Hospital |
3rd Floor, Smt Sharada Madhav Pai
OPD building
Department of General Surgery
Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA |
9406869839
ridhidhadwaiwale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria-
1. Age 18 to 80 years
2. Patients consenting to be part of the study
3. Patients with Type 2 Diabetes Mellitus
4. Patients undergoing lower limb amputation (above knee and below knee amputation)
5. Patient undergoing re-amputation in different admissions or after 30 days
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria-
1. Guillotine amputation
2. Above knee amputation and Below Knee done in the outside hospital
3. Re-amputation in same admission or within 30 days of admission
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of development of surgical site infection post lower extremity amputation
|
22 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors affecting incidence of surgical site infection like age, sex, smoking, obesity, hematocrit levels |
22 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
20/05/2024 |
| 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="1"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
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)
|
This is an observational Longitudinal study. Study will be conducted in a single center in India. The primary outcome is to calculate Incidence of development of surgical site infection post lower extremity amputation in diabetic population. We also plan to estimate factors affecting incidence of surgical site infection like age, sex, smoking, obesity, hematocrit levels. Surgical site infections are known to decrease the functionality of the amputees and increases the dependency. Identifying the predictors helps the surgeons tailor management based on individual patient profile and in implementing measures to reduce likelihood of infections. Surgical site infections are major cause of patient morbidity and impose substantial financial burden on patient and the healthcare system. |