| CTRI Number |
CTRI/2024/11/077310 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of local flaps for closure of complex facial laceration |
|
Scientific Title of Study
|
Outcomes Of Complex Facial Lacerations Using Prepared versus Conventional Surgical Debridement- A Randomised Clinical Trial |
| 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 Rahul Bichile |
| Designation |
Post graduate |
| Affiliation |
KAHERs KLE Vishwanath Katti Institute of dental sciences |
| Address |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences Oral and Maxillofacial Surgery OPD number 5
Nehru Nagar
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
8779191723 |
| Fax |
|
| Email |
rahulsbichile@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejraj P Kale |
| Designation |
Professor |
| Affiliation |
K.L.E V.K Institute of Dental Sciences |
| Address |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences Department five Oral and Maxillofacial Surgery Nehru Nagar Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9448472891 |
| Fax |
|
| Email |
tejrajkale@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejraj P Kale |
| Designation |
Professor |
| Affiliation |
K.L.E V.K Institute of Dental Sciences |
| Address |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences Department five Oral and Maxillofacial Surgery Nehru Nagar Belgaum
KARNATAKA
590010
India |
| Phone |
9448472891 |
| Fax |
|
| Email |
tejrajkale@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Rahul Bichile
KLE Vishwanath Katti Institute of Dental Sciences
department of oral and maxillofacial surgery
OPD number 5
Nehru Nagar
Belagavi
Karnataka
PIN code 590010
India |
|
|
Primary Sponsor
|
| Name |
Dr Rahul Bichile |
| Address |
Dr Rahul Bichile
KLE Vishwanath Katti Institute of Dental Sciences
department of oral and maxillofacial surgery
OPD number 5
Nehru Nagar
Belagavi
Karnataka
PIN code 590010
India |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Rahul Bichile |
KLEs Dr Prabhakar Kore Hospital |
Department of trauma care and emergency medicine
Sagar floor
KLEs Dr Prabhakar Kore Hospital
Nehru Nagar
Belgaum 590010
Belgaum
KARNATAKA |
8779191723
rahulsbichile@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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 |
Conventional Surgical Debridement |
Conventional Surgical Debridement will be aimed at approximation by conservative debridement without drawing an excisional line and debridement will be performed only to the extent that the approximation is possible.
5-0 Ethilon will be used for closure of the cutaneous layer and 3-0 Vicryl will be used for the subcutaneous layer. |
| Intervention |
Prepared Surgical Debridement |
After cleaning of wound and surrounding skin wound will be flushed with normal saline. In Prepared Surgical debridement area will be anesthetized using local or regional anesthesia. Afterwards approximation of tissues with as minimal injuries as possible by removal beyond the severely lacerated, ragged wound edge or partially avulsed segment in the wound edge will be done. Bleeding will be controlled, with skin marker pen design will be drawn according to aforementioned goal and wound excision, an incision will be performed. Various types of Local Flap Design will be applied in case of excessive tension or for preserving facial anatomical symmetry.
5-0 Ethilon will be used for closure of the cutaneous layer and 3-0 Vicryl will be used for the subcutaneous layer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will be visiting casualty with Facial Laceration will be included.
Patients with either grade I or grade II Complex Facial Lacerations will be included. |
|
| ExclusionCriteria |
| Details |
Patients taking any medication for chronic skin disease.
Patients who have Open fractures at the laceration site and having degloving injuries.
Facial laceration with superficial or sharp wound edges will be excluded.
Patients not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Scar outcome using Scar Cosmesis Assessment and Rating score between the two groups will be done. |
7th day
3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of complications such as infection and wound dehiscence between the two groups will be done using Southampton scoring system. |
7th day
3rd month |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
02/12/2024 |
| 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="2"
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
|
This study aims to assess and compare the outcomes of complex facial lacerations using Prepared surgical debridement with Conventional surgical debridement. Objectives of this study are to compare cosmetic outcomes of Prepared surgical debridement versus Conventional surgical debridement and to compare the incidence of complications such as infection and wound dehiscence between the two groups. This study will help in improving the quality of Lacerated wound management and wound care. |