Trial Outcomes & Findings for PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty (NCT NCT00943150)

NCT ID: NCT00943150

Last Updated: 2013-01-01

Results Overview

Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures. Acute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Immediately postoperative
• Results posted on: 2013-01-01

Participant Flow

Participant milestones

Measure	PEAK PlasmaBlade The PEAK PlasmaBlade for the abdominoplasty procedure.	Standard of Care (SOC) The scalpel and electrocautery will be used for the abdominoplasty procedure.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty

Baseline characteristics by cohort

Measure	PEAK PlasmaBlade n=10 Participants The PEAK PlasmaBlade will be used for the abdominoplasty procedure.	Standard of Care (SOC) n=10 Participants The scalpel and electrocautery will be used for the abdominoplasty procedure.	Total n=20 Participants Total of all reporting groups
Age Continuous	42.11 years FULL_RANGE 9.41 • n=5 Participants	44.40 years FULL_RANGE 10.72 • n=7 Participants	43.26 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately postoperative

Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.

Acute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation.

Outcome measures

Measure	PEAK PlasmaBlade n=10 Participants A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.	Electrocautery n=10 Participants The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.	Scalpel The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
Acute Thermal Injury Depth	195 micrometers Standard Deviation 127	763 micrometers Standard Deviation 208	—

PRIMARY outcome

Timeframe: 0, 3, and 6 weeks

Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.

Outcome measures

Measure	PEAK PlasmaBlade n=20 Participants A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.	Electrocautery n=20 Participants The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.	Scalpel n=20 Participants The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
Inflammatory Cell Count CD3+ 0 weeks	93 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	120 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	138 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.
Inflammatory Cell Count CD3+ 3 weeks	207 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	239 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	171 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.
Inflammatory Cell Count CD3+ 6 weeks	216 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	223 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	196 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.
Inflammatory Cell Count CD68+ 0 weeks	71 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	75 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	87 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.
Inflammatory Cell Count CD68+ 3 weeks	201 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	263 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	173 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.
Inflammatory Cell Count CD68+ 6 weeks	232 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	185 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.	202 cells per square millimeter Standard Deviation NA Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.

SECONDARY outcome

Timeframe: 0 to 10 days postoperatively

Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.

Outcome measures

Measure	PEAK PlasmaBlade n=9 Participants A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.	Electrocautery n=10 Participants The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.	Scalpel The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
Total Drainage Output	654.89 mL Standard Deviation 217.74	887.70 mL Standard Deviation 325.79	—

SECONDARY outcome

Timeframe: Intraoperative

Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.

The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.

Outcome measures

Measure	PEAK PlasmaBlade n=9 Participants A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.	Electrocautery n=10 Participants The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.	Scalpel The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
Change in Hemoglobin	-0.68 g/dL Standard Deviation 1.03	-1.62 g/dL Standard Deviation 1.21	—

SECONDARY outcome

Timeframe: Intraoperative and postoperative (0 to 10 days)

Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.

Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.

Outcome measures

Measure	PEAK PlasmaBlade n=9 Participants A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.	Electrocautery n=10 Participants The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.	Scalpel The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
Narcotic Consumption Intraoperative	3.82 Fentanyl microgram units/g Standard Deviation 2.26	4.92 Fentanyl microgram units/g Standard Deviation 1.72	—
Narcotic Consumption Postoperative (0 to 10 days)	2.39 Fentanyl microgram units/g Standard Deviation 2.26	3.33 Fentanyl microgram units/g Standard Deviation 2.75	—

SECONDARY outcome

Timeframe: Postoperative (0 to 10 days)

Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.

Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.

Outcome measures

Measure	PEAK PlasmaBlade n=9 Participants A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.	Electrocautery n=10 Participants The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.	Scalpel The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
Postoperative Pain Levels	2.15 units on a scale Standard Deviation 1.05	3.30 units on a scale Standard Deviation 2.72	—

SECONDARY outcome

Timeframe: Postoperative (0 to 10 days)

Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.

Sum of activity over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their activity level by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.

Outcome measures

Measure	PEAK PlasmaBlade n=9 Participants A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.	Electrocautery n=10 Participants The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.	Scalpel The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
Activity Level	452.78 units on a scale Standard Deviation 139.57	347.00 units on a scale Standard Deviation 165.92	—

SECONDARY outcome

Timeframe: Postoperative (0 to 10 days)

Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.

Sum of diet volume (i.e., how much food the subject ate) over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their diet volume by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.

Outcome measures

Measure	PEAK PlasmaBlade n=9 Participants A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.	Electrocautery n=10 Participants The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.	Scalpel The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
Diet Volume	701.11 units on a scale Standard Deviation 160.97	470.50 units on a scale Standard Deviation 243.35	—

Adverse Events

PEAK PlasmaBlade

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care (SOC)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PEAK PlasmaBlade n=10 participants at risk The PEAK PlasmaBlade will be used for the abdominoplasty procedure.	Standard of Care (SOC) n=10 participants at risk The scalpel and electrocautery will be used for the abdominoplasty procedure.
Surgical and medical procedures Seroma	0.00% 0/10	10.0% 1/10 • Number of events 1
Surgical and medical procedures Extended drainage period	10.0% 1/10 • Number of events 1	0.00% 0/10
Infections and infestations Infection	0.00% 0/10	20.0% 2/10 • Number of events 2

Additional Information

Robert Swain, PhD

Medtronic Surgical Technologies

Phone: (+1-603) 294-5428

Email: robert.e.swain@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60