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

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Procedure: Diathermy; Procedure: Harmonic Scalpel

Study type: Interventional

Funder types: Other

Identifiers

NCT01092468

2009-08-063

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• head and neck reconstruction with perforator flap
• informed consent from the patient

Exclusion criteria

• coagulation problem
• refused to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

Diathermy

Placebo Comparator group

Description:

Perforator flap elevation using conventional diathermy technique

Treatment:

Procedure: Diathermy

Harmonic Scalpel

Active Comparator group

Description:

Perforator flap elevation using Harmonic Scalpel

Treatment:

Procedure: Harmonic Scalpel