Trial Outcomes & Findings for Harmonic Versus Electro Surgery in Lower Body Lift Procedures (NCT NCT00522171)
NCT ID: NCT00522171
Last Updated: 2009-12-09
Results Overview
Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure
Recruitment status
TERMINATED
Target enrollment
30 participants
Primary outcome timeframe
From the time of drain placement to time of drain removal (</= 770 hours)
Results posted on
2009-12-09
Participant Flow
Participant milestones
| Measure |
Electro Surgery
Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
|
Harmonic® Technology
Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Harmonic Versus Electro Surgery in Lower Body Lift Procedures
Baseline characteristics by cohort
| Measure |
Electro Surgery
n=15 Participants
Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
|
Harmonic® Technology
n=15 Participants
Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
39.13 years
STANDARD_DEVIATION 10.239 • n=5 Participants
|
38.13 years
STANDARD_DEVIATION 8.105 • n=7 Participants
|
38.63 years
STANDARD_DEVIATION 9.088 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time of drain placement to time of drain removal (</= 770 hours)Population: ITT
Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure
Outcome measures
| Measure |
Electro Surgery
n=15 Participants
Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
|
Harmonic® Technology
n=15 Participants
Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications.
|
|---|---|---|
|
Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal
|
2163.03 milliliter
Standard Deviation 756.295
|
1863.60 milliliter
Standard Deviation 1471.390
|
SECONDARY outcome
Timeframe: From drain placement to drain removal (</= 770 hours)Population: terminated study
Total number of hours from drain placement to drain removal
Outcome measures
Outcome data not reported
Adverse Events
Electro Surgery
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Harmonic® Technology
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Electro Surgery
n=15 participants at risk
Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
|
Harmonic® Technology
n=15 participants at risk
Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea, MedDRA Version 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
wound dehiscence, MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
Other adverse events
| Measure |
Electro Surgery
n=15 participants at risk
Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
|
Harmonic® Technology
n=15 participants at risk
Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA ,MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo, MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Nausea; MedDRA 10.0
|
40.0%
6/15 • Number of events 6
|
40.0%
6/15 • Number of events 6
|
|
Gastrointestinal disorders
constipations; MedDRA 10.0
|
13.3%
2/15 • Number of events 2
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Chills; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
General disorders
impaired healing; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Pyrexia; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Application site reaction; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Application site vesicles; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
General disorders
fatigue; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
sinusitis;MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
infection; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
staphyloccal infection; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
vaginal infection; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
abdominal distension; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
abdominal haematoma; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
abdominal rigidity; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
seroma; MedDRA 10.0
|
33.3%
5/15 • Number of events 5
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
anaemia postoperative; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
device leakage; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
medical device pain; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
procedural nausea; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Investigations
body temperature increased; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Investigations
blood pressure decreased; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Investigations
lumbar puncture; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
fluid retention; MedDRA 10.0
|
20.0%
3/15 • Number of events 3
|
33.3%
5/15 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
pain in extremity; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
dizziness; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
33.3%
5/15 • Number of events 5
|
|
Nervous system disorders
headache; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
hypoaesthesia; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
intercranial hypotension; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
syncope; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
anxiety; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
insomnia; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
urge incontinence; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Reproductive system and breast disorders
perineal pain; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
respiratory disorder; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
pruritis; MedDRA 10.0
|
13.3%
2/15 • Number of events 2
|
40.0%
6/15 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
blister; MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
erythema; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
hypertension; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
ischaemia; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
thrombosis; MedDRA 10.0
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Application site Excoriation, medDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Asthenia, MedDRA 10.0
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has at least 60 days for review to ensure non disclosure of Confidential information. If Study is a multicenter study, PI agrees that the first publication shall include results from all PIs contributing data. If multicenter publication is not submitted within 12 months,or after Sponsor confirms there will be no multicenter Study publication, the Institution and/or such PI may publish the results from their respective site individually in accordance with this paragraph.
- Publication restrictions are in place
Restriction type: OTHER