Trial Outcomes & Findings for Study to Compare Negative Pressure Wound Therapy or Standard Dressings After Orthopedic Surgery (NCT NCT02064270)

NCT ID: NCT02064270

Last Updated: 2018-04-17

Results Overview

Visual Analog Pain Scale (VAS): PICO Study Incision Healing Assessment Form. Used to represent the assessment of incision healing based on in-person visual appearance, or appearance based on standard digital photograph. This number is reported as a total score on a 0-100 scale, with 0 being poor incision healing and 100 being excellent incision healing.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 526 participants
• Primary outcome timeframe: 35 days (+/- 14 days)
• Results posted on: 2018-04-17

Participant Flow

Participant milestones

Measure	Negative Pressure Wound Therapy Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings
Overall Study STARTED	263	263
Overall Study COMPLETED	201	231
Overall Study NOT COMPLETED	62	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Negative Pressure Wound Therapy n=201 Participants Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings n=231 Participants Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings	Total n=432 Participants Total of all reporting groups
Age, Continuous	60.7 years n=201 Participants	60.5 years n=231 Participants	60.6 years n=432 Participants
Sex: Female, Male Female	126 Participants n=201 Participants	137 Participants n=231 Participants	263 Participants n=432 Participants
Sex: Female, Male Male	75 Participants n=201 Participants	94 Participants n=231 Participants	169 Participants n=432 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	201 Participants n=201 Participants	231 Participants n=231 Participants	432 Participants n=432 Participants

PRIMARY outcome

Timeframe: 35 days (+/- 14 days)

Visual Analog Pain Scale (VAS): PICO Study Incision Healing Assessment Form. Used to represent the assessment of incision healing based on in-person visual appearance, or appearance based on standard digital photograph. This number is reported as a total score on a 0-100 scale, with 0 being poor incision healing and 100 being excellent incision healing.

Outcome measures

Measure	Negative Pressure Wound Therapy n=201 Participants Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings n=231 Participants Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings
Incision Appearance Based on VAS (Incision Healing Assessment Form)	83.4 units on a scale Standard Deviation 13.3	83.5 units on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: 35 days (+/- 14 days)

Incision Drainage:

1. None

2. Slight (barely noticed)

3. Moderate (significant amount, but did not have to change dressing)

4. Extensive (had to change dressing)

Outcome measures

Measure	Negative Pressure Wound Therapy n=194 Participants Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings n=223 Participants Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings
Drainage Amount Extensive (had to change dressing)	3 Participants	1 Participants
Drainage Amount None	178 Participants	211 Participants
Drainage Amount Slight (barely noticed)	9 Participants	9 Participants
Drainage Amount Moderate (significant amount, but did not have to	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 7 days

User-Friendliness of PICO device:

1. Easy to use (no difficulties, no instruction needed)

2. Slightly difficult (needed instruction)

3. Minor difficulties (but able to use effectively)

4. Difficult (not able to use effectively)

Outcome measures

Measure	Negative Pressure Wound Therapy n=131 Participants Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings
User-friendliness for Patient Easy to use	113 Participants	—
User-friendliness for Patient Slightly difficult	11 Participants	—
User-friendliness for Patient Minor difficulties	7 Participants	—
User-friendliness for Patient Difficult	0 Participants	—

SECONDARY outcome

Timeframe: 35 days (+/- 14 days)

Complications experienced by the subject within the study period time-frame will be recorded.

Outcome measures

Measure	Negative Pressure Wound Therapy n=201 Participants Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings n=231 Participants Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings
Number of Participants With Complications	27 participants	41 participants

SECONDARY outcome

Timeframe: 35 days (+/- 14 days)

Information regarding the subject returning to the operating room within the research study time-frame will be recorded.

Outcome measures

Measure	Negative Pressure Wound Therapy n=193 Participants Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings n=222 Participants Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings
Return to the Operating Room Return to OR	193 Participants	4 Participants
Return to the Operating Room No Return to OR	0 Participants	218 Participants

SECONDARY outcome

Timeframe: 35 days (+/- 14 days)

The need for additional antibiotics will be recorded.

Outcome measures

Measure	Negative Pressure Wound Therapy n=193 Participants Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings n=223 Participants Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings
Need for Antibiotics Need for additional antibiotics	25 Participants	30 Participants
Need for Antibiotics No need for additional antibiotics	168 Participants	193 Participants

Adverse Events

Negative Pressure Wound Therapy

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Dressings

Serious events: 6 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Negative Pressure Wound Therapy n=201 participants at risk Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings n=231 participants at risk Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings
Surgical and medical procedures Deep Infection Requiring Additional Surgery	2.5% 5/201 • 1 year	2.6% 6/231 • 1 year

Other adverse events

Measure	Negative Pressure Wound Therapy n=201 participants at risk Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	Standard Dressings n=231 participants at risk Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings
Infections and infestations Superficial Infection	1.5% 3/201 • 1 year	2.2% 5/231 • 1 year

Additional Information

Stacee Clawson, Research Manager

University of Missouri, Department of Orthopaedic Surgery

Phone: 5738849017

Email: clawsons@health.missouri.edu

Results disclosure agreements

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