Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap Elevation for Head and Neck Reconstruction

Cancer Clinical Trial

Official title:

Prospective, Randomised, Single-blinded Study : Comparison of Harmonic Scalpel to Conventional Diathermy in Perforator Flap

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092468
• Other study ID #: 2009-08-063
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2010
• Last updated: October 2, 2011
• Start date: January 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to compare the efficacy of Harmonic Scalpel with conventional diathermy technique in terms of reducing elevation time and perioperative complications of perforator flaps for head and neck reconstruction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• head and neck reconstruction with perforator flap

• informed consent from the patient

Exclusion Criteria:

• coagulation problem

• refused to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• Diathermy
flap dissection with conventional diathermy
• Harmonic Scalpel
flap dissection using harmonic scalpel (FOCUS)

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flap elevation time: from identification of skin perforator to completion of dissection to main pedicle		1 hour after completion of flap elevation	No
Secondary	intraoperative complications: bleeding, perforator injury (thermal, mechanical)		1 hour after completion of flap elevation	Yes
Secondary	postoperative drainage amount		1 week after flap inset	No
Secondary	postoperative pain measured by visual analogue scale (VAS)		1 week after completion of flap elevation	No