| CTRI Number |
CTRI/2024/07/070834 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Collagen dressing vs chlorhexidine gauge dressing] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between collagen dressing and chlorhexidine gauge dressing of split thickness skin grafting donor site during surgery for better wound healing |
|
Scientific Title of Study
|
Comparison of wound healing of split thickness skin grafting donor site with collagen
dressing vs chlorhexidine gauge dressing intraoperatively A one year randomized
control trial at 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 |
Dr Puchakayala Harshavardhan Reddy |
| Designation |
Junior Resident |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery KLE Jawaharlal Nehru Medical
College
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9346702306 |
| Fax |
|
| Email |
harshas.96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj D Togale |
| Designation |
Professor |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery KLE Jawaharlal Nehru Medical
College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9844706266 |
| Fax |
|
| Email |
zapmanojtogale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj D Togale |
| Designation |
Professor |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery KLE Jawaharlal Nehru Medical
College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9844706266 |
| Fax |
|
| Email |
zapmanojtogale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of General Surgery KLE Jawaharlal Nehru Medical
College Belgaum
KARNATAKA
590010
India |
|
|
Primary Sponsor
|
| Name |
Dr Puchakayala Harshavardhan Reddy |
| Address |
Department Of General Surgery, KLE Jawaharlal Nehru Medical
College Belgaum, Karnataka 590010, India |
| 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 Puchakayala Harshavardhan Reddy |
KLE’s Dr. Prabhakar Kore Hospital and Medical Research Centre |
Department Of General
Surgery, KLE
Jawaharlal Nehru
Medical College.
Nehru nagar,
Belgaum
590010
Belgaum
KARNATAKA |
9346702306
harshas.96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALING ULCERS |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
collagen dressing vs chlorhexidine gauge dressing |
comparison of wound healing of STSG donor site intraoperatively with
use of collagen dressings and
chlorhexidine gauge dressings between 2 groups. Group
A patients donor site dressing will be done with collagen sheets and
Group B patients will have chlorhexidine gauze dressing.
|
| Comparator Agent |
collagen sheet vs chlorhexidine gauge |
Comparison of wound healing of split thickness skin grafting donor site with collagen
dressing vs chlorhexidine gauge dressing intraoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years to 75 years
Patients undergoing Split thickness skin grafting
ASA grades 1 and 2
Patients willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
Age more than 75 years
Patient not willing for giving consent |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare wound healing of STSG donor site with
use of collagen dressings and chlorhexidine gauge dressing |
Results will be compared after 2 weeks of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The pain at the donor site is assessed using VAS
score and compared between 2 groups |
Pain assessed after 24 hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="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
|
The study is focused on comparison of wound healing of STSG donor site with
use of collagen dressings and chlorhexidine gauge dressings between 2 groups. Group
A patients donor site dressing will be done with collagen sheets and
Group B patients will have chlorhexidine gauze dressing, results
will be compared after 2 weeks. The pain at the donor site is assessed using VAS
score after 24 hours and wound healing is observed after 2 weeks, based on average reduction of size of wound in both the groups
will be compared. The results from both the groups will be compared after 2
weeks of surgery. |