| CTRI Number |
CTRI/2025/07/090286 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Wound Dressing] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EVALUATION OF EFFICACY OF WOUND DRESSING USING PARAFFIN GAUZE VS COLLAGEN DRESSING – A PROSPECTIVE CLINICAL STUDY |
|
Scientific Title of Study
|
Evaluation of efficacy of wound dressing using paraffin gauze vs collagen dressing - A prospective clinical study |
| 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 RAMYA PM |
| Designation |
POST GRADUATE RESEARCH SCHOLAR |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
No.14, RAMOHALLI CROSS, MYSORE ROAD, KUMBALAGODU
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
8660428406 |
| Fax |
|
| Email |
ramyapalani7630@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mamatha N S |
| Designation |
Professor and head of the department |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of oral and maxillofacial surgery
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9880194412 |
| Fax |
|
| Email |
Mamathans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAMATHA NANJAPPA SIDDLINGAPPA |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9880194412 |
| Fax |
|
| Email |
Mamathans@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ramya PM |
| Address |
Department of oral and maxillofacial surgery
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu
Bangalore - 560074 |
| 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 RAMYA PM |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
Department of oral and maxillofacial surgery
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu
Bangalore Rural
KARNATAKA |
8660428406
ramyapalani7630@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Collagen dressing |
Type 1 bovine collagen will be used for dressing and will be assessed on 3rd, 14th and 21st day |
| Comparator Agent |
Paraffin Gauze |
Paraffin gauze dressing will be used on the abrasion on 3rd, 14th and 21st day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All male and female patients above 18 years of age group.
2. Abrasions over maxillofacial areas.
|
|
| ExclusionCriteria |
| Details |
1. Seropositive patients (HIV, Hepatitis b and Hepatitis c)
2. Immunocompromised patients where wound healing may be affected.
3. Patient with lacerated wounds
4. Patient with burn injuries
5. Pregnant and lactating women
6. Patient with deep abrasion or complete tissue loss
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain assessment post operatively
2.Degree of Epithelization
3.Other outcomes like infection, hypertrophic scar, hypo and hyper pigmented scars
|
1.Pain assessment post operatively 3rd day
2.Degree of Epithelization on 7th, 14th and 21 day
3.Other outcomes like infection, hypertrophic scar, hypo and hyper pigmented scars
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="2"
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
|
1. The patients fulfilling the inclusion criteria will be up taken for the study after obtaining informed consent. 2. The wound is inspected for its type, size, and depth. It is also inspected for any infection or discharge of pus. 3. The wound is then debrided using saline first and then betadine solution. It is then irrigated using saline solution. 4. In group I patients, paraffin gauze dressing is cut to fit the size and shape of the wound is placed over the abrasion ensuring it covers the entire wound area and extends slightly beyond its edges. In group II patients, collagen dressing is placed over the abrasion ensuring full coverage, the dressing is gently press down to ensure there is no air pockets that might hamper the healing. 5. The dressing is then secured using medical tape, bandages, or a self-adhesive dressing. 6. The patient is called for regular follow-up on the 7th ,14th, 21st day to evaluate healing 7. The parameters such as grade of abrasion, pain assessment, epithelization, infection, hyper trophic scars are assessed. |