| CTRI Number |
CTRI/2024/02/062345 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Suture Material] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two different stitching materials for repair of hole in upper jaw |
|
Scientific Title of Study
|
Comparative Evaluation of clinical outcome between 4-0 Polydioxanone and 4-0 vicryl suture for closure in Primary Cleft Palate Surgery |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrishty Bhardwaj |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Oral and Maxillofacial surgery, Saveetha Dental college and hospital
Department of Oral and Maxillofacial surgery, Saveetha Dental college and hospital
Chennai
TAMIL NADU
600077
India |
| Phone |
9986212358 |
| Fax |
|
| Email |
shrishtybhardwaj15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemavathy O R Muralidoss |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha Dental college and hospital
Department of Oral and Maxillofacial Surgery, Saveetha Dental college and hospital
Chennai
TAMIL NADU
600077
India |
| Phone |
9986212358 |
| Fax |
|
| Email |
hemadocmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrishty Bhardwaj |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha Dental college and Hospital
Department of Oral and Maxillofacial Surgery, Saveetha Dental college and Hospital
Chennai
TAMIL NADU
600077
India |
| Phone |
9986212358 |
| Fax |
|
| Email |
shrishtybhardwaj15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of oral and Maxillofacial surgery, Saveetha dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Shrishty Bhardwaj |
| Address |
Department of Oral and Maxillofacial Surgery, Saveetha Dental college and Hospital |
| 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 Shrishty Bhardwaj |
Saveetha Dental college and hospital |
Department of Oral and Maxillofacial Surgery, Clinic 20
Chennai
TAMIL NADU |
9986212358
shrishtybhardwaj15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College- Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q355||Cleft hard palate with cleft softpalate, (2) ICD-10 Condition: Q359||Cleft palate, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Polydioxanone Suture Material |
4-0 PDS Suture material used to close oral mucosal layer in primary palatoplasty
6 months follow up |
| Comparator Agent |
Polyglactin Suture Material |
4-0 Vicryl Suture material used to close oral mucosal layer in primary palatoplasty |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary cleft palate
Non syndromic patients |
|
| ExclusionCriteria |
| Details |
Syndromic Patients
Palatal Fistula
Medically compromised patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound Dehiscence, Wound healing, Mucosal Scarring, Suppuration |
follow up 1 week, 1 month, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mucosal Scarring, Suppuration |
follow up 1 week, 1 month, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2024 |
| 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="0"
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
|
â—Vicryl is an absorbable, synthetic
suture which is a braided copolymer of glycolic and lactic acid that is surface
treated with polyglactin 370 and calcium stearate and has received gamma
radiation. This radiation alters the suture material’s molecular structure and
enhances its absorption rate in vivo.
â—Polydioxanone (PDS) or poly-p-dioxanone
is a slowly absorbable monofilament suture composed of the polyester, poly
(p-dioxanone). This is a monofilament with greater strength than monofilament
nylon and polypropylene, and with less tissue drag than the multifilament
materials.
Aim: To Compare and evaluate wound healing using
4-0 PDS and 6-0 Vicryl in cleft palate surgery.
Null Hypothesis: There is no difference in
surgical outcome between the suture materials after primary palatoplasty |