| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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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