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CTRI Number  CTRI/2022/03/041194 [Registered on: 17/03/2022] Trial Registered Prospectively
Last Modified On: 21/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare and evaluate wound healing outcome of superoxidised solution and calendula officinalis flower extract used for local wound care in patients of oral squamous cell carcinoma having postoperative wound dehiscence  
Scientific Title of Study   To evaluate and compare the wound healing outcome of Superoxidised solution and Calendula Officinalis flower extract used for local wound care in patients of oral squamous cell carcinoma having postoperative wound dehiscence: A randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raj kumar Chakraorty 
Designation  Fellow in Oral Oncology 
Affiliation  Sharad Pawar Dental College and hospital 
Address  Room no 4,Department of Oral and maxillofacial surgery,Sharad pawar dental college and hospital.Sawangi(Meghe)

Wardha
MAHARASHTRA
442004
India 
Phone  9207324979  
Fax    
Email  rkc.dent@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Bhola 
Designation  Professor and Head of department 
Affiliation  Sharad Pawar dental College and hospital 
Address  Room no 4,Department of Oral and maxillofacial surgery,Sharad pawar dental college and hospital.Sawangi(Meghe)

Wardha
MAHARASHTRA
442004
India 
Phone  9970070607  
Fax    
Email  drnitinbhola@gmail.com  
 
Details of Contact Person
Public Query  
Name  Raj Kumar Chakraborty 
Designation  Fellow in Oral oncology 
Affiliation  Sharad Pawar dental College and hospital 
Address  Room no 4,Department of Oral and maxillofacial surgery,Sharad pawar dental college and hospital.Sawangi(Meghe)

Wardha
MAHARASHTRA
442004
India 
Phone  9207324979  
Fax    
Email  rkc.dent@gmail.com  
 
Source of Monetary or Material Support  
Sharad Pawar Dental college and Hospital,Wardha,Maharashtra. 
 
Primary Sponsor  
Name  Sharad Pawar Dental College Hospital  
Address  Sharad Pawar Dental College & Hospital Sawangi Meghe Wardha Maharashtra 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Raj Kumar Chakraborty  Sharad Pawar Dental College & Hospital   Room no 4,Department of Oral and maxillofacial surgery,Sharad pawar dental college and hospital.Sawangi(Meghe).Pin-442004
Wardha
MAHARASHTRA 		 9207324979

rkc.dent@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (2) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (3) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (4) ICD-10 Condition: C000||Malignant neoplasm of external upper lip, (5) ICD-10 Condition: C001||Malignant neoplasm of external lower lip, (6) ICD-10 Condition: C002||Malignant neoplasm of external lip, unspecified, (7) ICD-10 Condition: C003||Malignant neoplasm of upper lip, inner aspect, (8) ICD-10 Condition: C004||Malignant neoplasm of lower lip, inner aspect, (9) ICD-10 Condition: C005||Malignant neoplasm of lip, unspecified, inner aspect, (10) ICD-10 Condition: C006||Malignant neoplasm of commissure of lip, unspecified, (11) ICD-10 Condition: C008||Malignant neoplasm of overlappingsites of lip, (12) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (13) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (14) ICD-10 Condition: C040||Malignant neoplasm of anterior floor of mouth, (15) ICD-10 Condition: C041||Malignant neoplasm of lateral floor of mouth, (16) ICD-10 Condition: C048||Malignant neoplasm of overlappingsites of floor of mouth, (17) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (18) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (19) ICD-10 Condition: C051||Malignant neoplasm of soft palate, (20) ICD-10 Condition: C052||Malignant neoplasm of uvula, (21) ICD-10 Condition: C058||Malignant neoplasm of overlappingsites of palate, (22) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (23) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (24) ICD-10 Condition: C061||Malignant neoplasm of vestibule ofmouth, (25) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, (26) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (27) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (28) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (29) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue, (30) ICD-10 Condition: C028||Malignant neoplasm of overlappingsites of tongue, (31) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calendula officinalis flower extract  dose-1 ml if calendula mother tincture frequency-twice daily route of administration-topical application duration of therapy-20 days 
Comparator Agent  Superoxidised solution  dose-1 ml of superoxidised solution containing hypochlorous acid 0.003%,oxidised water 99.97%,sodium chloride 0.023%,sodium hypochlorite 0.004% frequency-twice daily route of administration-topical application duration of therapy-20 days 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)Patients who have undergone surgical intervention for management of oral squamous cell carcinoma(OSCC) with Neck dissection
2)Patients who have a wound dehiscence of less than equal to 2 cm² post OSCC surgery
3)Patients requiring no surgical intervention for correction of wound dehiscence.
 
 
ExclusionCriteria 
Details  1)Previous history of Radiotherapy & chemotherapy
2)Previous history of neck dissection
3)Recurrence of OSCC
4)Coagulation disorder
5)Patient unfit for surgery
6)Patients with known allergy to herbal medication
 
 
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)Size of wound
2)Depth of wound
3)Edges of wound 4)Undermining 5)Necrotic tissue type
6)Necrotic tissue amount
7)Exudate type
8)Exudate amount in wound
9)Skin color of surrounding wound.
10)Peripheral tissue edema
11)Peripheral tissue Induration
12)Granulation tissue
13)Epithelization 		 WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence 
 
Secondary Outcome  
Outcome  TimePoints 
Allergy to Calendula Officinalis flower extract   On Day 1 of topical application 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   25/03/2022 
Date of Study Completion (India) 13/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rkc.dent@gmail.com].

  6. For how long will this data be available start date provided 01-10-2022 and end date provided 30-09-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Wound dehiscence(29%) is a known complication of oral cancer surgery.They can be divided in to major and minor complications.Major complications include extended wound dehiscence which require surgical revision and minor complications include regular  wound dehiscence that require only local dressings and therapy and no further surgical procedure.
The criterion to differentiate a regular or extended wound dehiscence can be the presence of dehiscent area less than or equal to two centimeter square in regular wound dehiscence.
 Superoxidised solution has been used for wound healing post surgery.It moistens, lubricates ,debrides and reduces microbial load.
Similarly Calendula Officinalis flower extract has been studied for wound healing post surgery.It has antiinflammatory,antibacterial,antiviral,antifungal, proangiogenic and anti oxidant properties.There are reports of local  allergy too.
A clinical trial  objectively comparing the above mentioned interventions is required.
 This study is a randomized ,single blind,parellel droup, mono centric trial to evaluate and  compare the the wound healing outcome of superoxidised solution and Callendula Officinalis flower extract used for local wound care in patients of oral squamous cell carcinoma having post operative wound dehiscence.
The primary outcome is based on thirteen criteria of the Bates Jensen wound assessment tool .All these parameters will be evaluated on day1,5,10,15 and 21 post wound dehiscence. 
the secondary outcome will be to assess if calendula can cause any local allergy. 
 
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