| CTRI Number |
CTRI/2025/02/080221 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A one-year observational study comparing wound size in chronic ulcers between collagen dressings and conventional dressings at a tertiary care hospital. |
|
Scientific Title of Study
|
A one-year observational study comparing size of wound after being subjected to collagen dressings and conventional dressings at a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrey Siddharth |
| Designation |
Junior Resident MS General Surgery |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
JNMC, NEHRU NAGAR, BELAGAVI, KARNATAKA
Sahyog Hospital, BORO, GIRIDIH, JHARKHAND
Belgaum
KARNATAKA
590010
India |
| Phone |
7666671875 |
| Fax |
|
| Email |
shrey.siddharth15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. A P BELLAD |
| Designation |
PROFESSOR, MS General Surgery |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
JNMC, NEHRU NAGAR, BELAGAVI, KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9448112599 |
| Fax |
|
| Email |
anilbellad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shrey Siddharth |
| Designation |
Junior Resident MS General Surgery |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
JNMC, NEHRU NAGAR, BELAGAVI, KARNATAKA
Sahyog Hospital, BORO, GIRIDIH, JHARKHAND
KARNATAKA
590010
India |
| Phone |
7666671875 |
| Fax |
|
| Email |
shrey.siddharth15@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. SHREY SIDDHARTH
junior resident, department of general surgery, JNMC, belagavi. |
|
|
Primary Sponsor
|
| Name |
DR SHREY SIDDHARTH |
| Address |
JNMC, NEHRU NAGAR, BELAGAVI |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 |
| SHREY SIDDHARTH |
Department of General Surgery, JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI. |
DEPARTMENT OF GENERAL SURGERY, Jawaharlal Nehru Medical College, NEHRU NAGAR, BELAGAVI, KARNATAKA
Belgaum
KARNATAKA |
7666671875
shrey.siddharth15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
size of chronic wound |
the size of chronic wound will be compared at the beginning and at the end of 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient with chronic ulcer (more than 6 weeks duration) (diabetic ulcer, venous ulcer, arterial ulcer, pressure ulcer, non-healing ulcer)
2) Chronic ulcers of 6cm ±3cm diameter
3) Patient giving informed consent
4) Patient between 18–60-year age group
|
|
| ExclusionCriteria |
| Details |
1) Patient with infective ulcer
2) Critically ill patient
3) Patient refusing
4) Any evidence of underlying bone osteomyelitis
5) Malignancy
6) immunocompromised state
7) Age more than 60 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Collagen dressing helps in better wound healing as compared to conventional dressing. |
Collagen dressing helps in better wound healing as compared to conventional dressing. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing the rate of wound healing after being subjected to collagen dressing and conventioanl dressing. |
comparing the rate of wound healing after being subjected to collagen dressing and conventioanl dressing. |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
12/02/2025 |
| 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)
|
Not Applicable |
| 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
|
Collagen dressing increases the rate of wound healing as compared to
moistened gauze. Further, it also reduces the follow up period and antibiotic
use significantly as compared to conventional dressing. The use of collagen granules dressing accelerates the rate of wound
healing in chronic ulcers. Thus reducing the ulcer size can help patient to
early return to work. Early return to work does reduce the financial burden on
the patient. |