Trial Outcomes & Findings for Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty (NCT NCT02355691)

Last Updated: 2018-04-17

Results Overview

A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale.

Recruitment status

TERMINATED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

(Single point evaluation)-2 weeks post surgery visit

Results posted on

2018-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	PREVENA Group Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery.	Standard Group Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
Overall Study STARTED	7	9
Overall Study 1st Postop Visit	7	9
Overall Study 2nd Postop Visit	7	9
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Reasons for withdrawal
Measure	PREVENA Group Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery.	Standard Group Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
Overall Study Loss of Research Personnel	7	9

Baseline Characteristics

Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PREVENA Group n=7 Participants Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery.	Standard Group n=9 Participants Patients will be treated with the standard absorptive dressing following total hip arthroplasty.	Total n=16 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	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	54.6 years n=5 Participants	57.6 years n=7 Participants	56.2 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Discharge location Skilled Nursing Facility	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Discharge location Home	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: (Single point evaluation)-2 weeks post surgery visit

Population: Measured outcomes for all patients that completed the treatment

Outcome measures

Outcome measures
Measure	PREVENA Group n=7 Participants Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery.	Standard Group n=9 Participants Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
Mean Wound Healing Scores by the ASEPSIS Criteria	0.57 units on a scale Interval 0.0 to 1.0	1.66 units on a scale Interval 0.0 to 16.0

SECONDARY outcome

Timeframe: (Single point evaluation)-6 weeks post surgery visit

Population: Measured all that enrolled and completed the treatment

The investigators will continue to monitor the patients for development of an acute postoperative infection. A deep infection refers to an infection below the superficial soft tissue and likely involving the prosthesis. This will be evaluated by the musculoskeletal infection society consensus on total joint infection. Criteria include:(Either one major criteria or four minor criteria) Major criteria Sinus track communicating with the prosthesis Two separate cultures from the joint positive for the same organism Minor criteria Elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) Elevated synovial leukocyte count Elevated synovial neutrophil percentage Purulent drainage from the joint One positive fluid culture from the joint Histological analysis of tissue showing more than 5 neutrophils per high power field in 5 fields

Outcome measures

Outcome measures
Measure	PREVENA Group n=7 Participants Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery.	Standard Group n=9 Participants Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
Number of Participants With Infection Deep Infection	0 Participants	0 Participants
Number of Participants With Infection No deep infection	7 Participants	9 Participants

Adverse Events

PREVENA Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PREVENA Group n=7 participants at risk Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery.	Standard Group n=9 participants at risk Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
Skin and subcutaneous tissue disorders Wound drainage	0.00% 0/7 • Patients that enrolled in the study were followed and seen at 2 weeks postoperatively. The study was terminated prior to patients returning for their 6 week visit so they were not seen by the research staff after 2 weeks. All patients were followed by chart review to confirm adverse events within 6 months of enrolling in the study. Personal examination at 2 weeks, chart review at 6 months.	11.1% 1/9 • Number of events 1 • Patients that enrolled in the study were followed and seen at 2 weeks postoperatively. The study was terminated prior to patients returning for their 6 week visit so they were not seen by the research staff after 2 weeks. All patients were followed by chart review to confirm adverse events within 6 months of enrolling in the study. Personal examination at 2 weeks, chart review at 6 months.

Additional Information

Scott Eskildsen, MD

UNC Orthopaedics

Phone: (919) 966-9166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place