Trial Outcomes & Findings for Comparison of Two Methods of Negative Pressure Wound Therapy (NCT NCT00724750)

NCT ID: NCT00724750

Last Updated: 2015-10-19

Results Overview

Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2015-10-19

Participant Flow

Participant milestones

Measure	G-SUC Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Gauze suction (G-SUC): Negative pressure wound therapy	Vacuum Assisted Closure Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy
Overall Study STARTED	45	42
Overall Study COMPLETED	45	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Methods of Negative Pressure Wound Therapy

Baseline characteristics by cohort

Measure	G-SUC n=45 Participants Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Gauze suction (G-SUC): Negative pressure wound therapy	Vacuum Assisted Closure n=42 Participants Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy	Total n=87 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	54 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	23 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	42 participants n=7 Participants	87 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.

Outcome measures

Measure	G-SUC n=45 Participants Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Gauze suction (G-SUC): Negative pressure wound therapy	Vacuum Assisted Closure n=42 Participants Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy
Percent Change Per Day in Wound Surface Area	-4.5 % change per day Interval -5.3 to -3.8	-4.9 % change per day Interval -6.0 to -3.8

PRIMARY outcome

Timeframe: 7 days

Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.

Outcome measures

Measure	G-SUC n=45 Participants Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Gauze suction (G-SUC): Negative pressure wound therapy	Vacuum Assisted Closure n=42 Participants Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy
Percent Change Per Day in Wound Volume	-8.4 % change per day Interval -9.5 to -7.2	-9.8 % change per day Interval -11.5 to -8.1

SECONDARY outcome

Timeframe: Participants were followed for the duration of inpatient stay, an average of 5 days.

Outcome measures

Measure	G-SUC n=45 Participants Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Gauze suction (G-SUC): Negative pressure wound therapy	Vacuum Assisted Closure n=42 Participants Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy
Failure to Maintain Dressing Because of Fluid or Suction Leaks	0 participants	4 participants

SECONDARY outcome

Timeframe: Participants were followed for the duration of inpatient stay, an average of 5 days.

Time was measured from the start of the dressing change until the initiation of suction.

Outcome measures

Measure	G-SUC n=45 Participants Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Gauze suction (G-SUC): Negative pressure wound therapy	Vacuum Assisted Closure n=42 Participants Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy
Average Time Spent on Dressing Changes	19 minutes Standard Deviation 6	31 minutes Standard Deviation 13

SECONDARY outcome

Timeframe: Participants were followed for the duration of inpatient stay, an average of 5 days.

Self-reported pain levels were used to assess pain. Patients were asked to rate their pain level according to the 0 to 10 linear analog scale immediately before, during, and after removal of the dressing. The average number of dressing changes for the G-SUC group was 4.5 (range 2-15) and the average number of dressing changes for the VAC group was 2.8 (range 2-6). The sum of pain intensity differences (SPID) was used to facilitate comparison of pain levels. The SPID score was calculated for each dressing change using the formula: (pain during - pain before) + (pain after - pain during). Higher values indicating greater pain.

Outcome measures

Measure	G-SUC n=45 Participants Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Gauze suction (G-SUC): Negative pressure wound therapy	Vacuum Assisted Closure n=42 Participants Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy
Pain Score With Dressing Changes	0.50 units on a scale Interval -0.11 to 1.11	1.73 units on a scale Interval 0.91 to 2.54

SECONDARY outcome

Timeframe: Participants were followed for the duration of inpatient stay, an average of 5 days.

Direct costs for each type of dressing were measured. In the VAC group, this included rental charges for the equipment and the cost of supplies. In the G-SUC group, this included the cost of supplies (suction canisters, catheters or drains, tubing, gauze, and adhesive drapes).

Outcome measures

Measure	G-SUC n=45 Participants Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Gauze suction (G-SUC): Negative pressure wound therapy	Vacuum Assisted Closure n=42 Participants Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy
Average Cost of Supplies and Rental	4.22 dollars Standard Deviation 1.57	96.51 dollars Standard Deviation 11.26

Adverse Events

G-SUC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vacuum Assisted Closure

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	G-SUC n=45 participants at risk Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Gauze suction (G-SUC): Negative pressure wound therapy	Vacuum Assisted Closure n=42 participants at risk Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy
Vascular disorders Hematoma	0.00% 0/45 • 1 month	2.4% 1/42 • 1 month

Other adverse events

Adverse event data not reported

Additional Information

Lawrence Gottlieb

University of Chicago

Phone: (773) 702-6302

Email: lgottlie@surgery.bsd.uchicago.edu

Results disclosure agreements

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