Overview

This trial is active, not recruiting.

Condition abdominal subcutaneous fat
Treatment abdominal plastic surgery
Sponsor Asklepios proresearch
Collaborator Ethicon Endo-Surgery
Start date February 2009
End date January 2011
Trial size 22 participants
Trial identifier NCT01262378, 2909, ASK # 1557

Summary

Prospective, non-randomized, controlled study to investigate the clinical outcome of surgery using the Harmonic knife vs the HF knife in patients requiring abdominoplastic surgery or body lift (Lockwood)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
surgery using the Harmonic knife
abdominal plastic surgery
Surgery for ABDOMINAL SUBCUTANEOUS FAT
(Active Comparator)
abdominal plastic surgery
Surgery for ABDOMINAL SUBCUTANEOUS FAT

Primary Outcomes

Measure
amount of seroma
time frame: first post operative day until hospital discharge

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years - willing to give consent - indication for abdominoplastic surgery - no contraindication for general anaesthesia Exclusion Criteria: - Smoking more than 10 p/day - Diabetes mellitus I or II - known neoplasms - not willing or able to conform with study requirements

Additional Information

Official title Clinical Outcome of the Seroma Amount Using the Harmonic vs the HF Knife for Surgery According to Lockwood and Abdominoplastic Surgery: A Prospective Controlled Study
Description Aim of the study is to measure amount of seroma in each interventional arm.
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by Asklepios proresearch.