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CTRI Number  CTRI/2014/04/004525 [Registered on: 04/04/2014] Trial Registered Prospectively
Last Modified On: 08/02/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two instruments used for flap reconstruction in oral cancer reconstruction 
Scientific Title of Study   A prospective randomized study comparing harmonic scalpel versus electro cautery for harvesting of pectoralis major myocutaneous flap in oral cancer reconstruction 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Paul Sebastian 
Designation  Professor of Surgical Oncology  
Affiliation  Regional Cancer Centre Thiruvananthapuram, 
Address  Division of Surgical Oncology
Division of Surgical Oncology
Thiruvananthapuram
KERALA
695011
India 
Phone  04712522222  
Fax  04712447454  
Email  psebastian2091@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sharath K Krishnan 
Designation  Senior Resident 
Affiliation  Regional Cancer Centre Thiruvananthapuram, 
Address  Division of Surgical Oncology
Division of Surgical Oncology
Thiruvananthapuram
KERALA
695011
India 
Phone  9400326326  
Fax  04712447454  
Email  sharathkkrishnan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sharath K Krishnan 
Designation  Senior Resident 
Affiliation  Regional Cancer Centre Thiruvananthapuram, 
Address  Division of Surgical Oncology
Division of Surgical Oncology
Thiruvananthapuram
KERALA
695011
India 
Phone  9400326326  
Fax  04712447454  
Email  sharathkkrishnan@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Paul Sebastian 
Address  Professor of Surgical Oncology Regional Cancer Centre, Thiruvananthapuram,  
Type of Sponsor  Other [Professor of Surgical Oncology ] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Nebu Abraham George  Assistant Professor, Division of Surgical Oncology Regional Cancer Centre, Thiruvananthapuram.  
Dr Shaji Thomas  Additional Professor, Division of Surgical Oncology, Regional Cancer Centre, Thiruvananthapuram.  
Dr Sharath K Krishnan  Senior Resident, Division of Surgical Oncology, Regional Cancer Centre, Thiruvananthapuram.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Paul Sebastian  Regional Cancer Centre, Thiruvananthapuram  Division of Surgical Oncology, Regional Cancer Centre
Thiruvananthapuram
KERALA 
04712522222
04712447454
psebastian2091@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HUMAN ETHICS COMMITTEE, REGIONAL CANCER CENTRE THIRUVANANTHAPURAM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Primary health condition studied is oral cancer and problems studied is flap related complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  flap harvesting by electrocautery  flap related complication 
Intervention  Flap harvesting by harmonic scalpel   flap related complication 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA
•Oral cancer patients requiring PMMC flap for
reconstruction after surgery
•Patients age 18 to 70
•An ECOG performance score of 0-1
•Fit to undergo general anesthesia
•Patient willing to give a valid informed consent
for the procedure
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA
• Blood dyscrasias / altered coagulation profile
• Known case of Collagen vascular disease
• Diabetes or hypertension of more than 15 years
duration
• Infection in chest wall or lower neck
• Any prior surgery on chest wall
• Any history of radiation to chest wall
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Blood loss during flap harvesting
Drains output measurement
Complication sought for at chest wound and flap recipient site
Hematoma
Seroma
Skin and subcutaneous infection
Flap vascularity changes –
partial/complete
 
Blood loss during flap harvesting, per operative
Drains output measurement, post operative
Complication sought for at chest wound and flap recipient site
in post operative period before discharge
Hematoma
Seroma
Skin and subcutaneous infection
Flap vascularity changes –
partial/complete
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Demographic and clinical details of the patients will be captured on a structured proforma.        After wide excision of the primary disease and neck dissection PMMC flap is harvested

Skin paddle marking and raising subcutaneous skin flap in both arms done with scalpel and electro cautery respectively

In Arm I myocutaneous flap elevation is done using Harmonic FOCUS shear connected to Ultrascision Harmonic generator 300(J&J)  which is calibrated at power 3 and power 5. The lateral edges of the muscle pedicle are not sutured.In Arm II electrocautery is used for myocutaneous flap tissue.The edges of muscle are sutured with absorbable suture after securing hemostasis.After elevation the flap is transferred on to the neck and the wounds are sutured with correct approximation and separate drainage kept for the neck and chest operative sites.The blood loss during flap harvesting is measured by the difference of the pre operative (Y) and post operative weight (X) of mops used during harvesting of the flap. ( X – Y) / 1.055(sp gravity blood) = volume of blood in ml.Daily monitoring of the drains with measurement done in milliliters from the neck and chest separately and  drain is removed when less than 50 ml .The cumulative volume drain volume of both neck and chest drain is recorded up to the time of removal of drain.Complication sought for at chest wound and flap recipient site1) Hematoma 2) Seroma 3)  Skin infection 4) Flap vascularity changes – partial/complete

ANALYSIS - Statistical analysis by Student t test to assess significant difference between two groups for quantitative variables such as blood loss and post operative drain.The Chi-Square test for categorical variant difference between two groups such as Hematoma, Seroma, Skin infection, Flap vascularity changes partial or complete. A P.05 was considered statistically significant.

 


 
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