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A clinical trial to study the effects of two instruments used for flap reconstruction in oral cancer reconstruction

A prospective randomized study comparing harmonic scalpel versus electro cautery for harvesting of pectoralis major myocutaneous flap in oral cancer reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004525
Enrollment
104
Registered
2014-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Primary health condition studied is oral cancer and problems studied is flap related complications

Interventions

Intervention1: Flap harvesting by harmonic scalpel: flap related complication Control Intervention1: flap harvesting by electrocautery: flap related complication

Sponsors

Dr Paul Sebastian
Lead Sponsor
Dr Nebu Abraham George
Collaborator
Dr Shaji Thomas
Collaborator
Dr Sharath K Krishnan
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 â?? partial/complete Timepoint: 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 â?? partial/complete

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr Sharath K Krishnan

Regional Cancer Centre Thiruvananthapuram,

sharathkkrishnan@gmail.com9400326326

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026