Trial Outcomes & Findings for Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications (NCT NCT03773575)

NCT ID: NCT03773575

Last Updated: 2026-02-12

Results Overview

Presence of any of the following post-procedure: * Dehiscence (skin or fascia) * Seroma * Lymph leak * Infection (superficial or deep, using CDC Surgical Site Infection criteria) * Hematoma * Ischemia * Necrosis

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 272 participants
• Primary outcome timeframe: 30 days post procedure
• Results posted on: 2026-02-12

Participant Flow

Participant milestones

Measure	Prevena PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care sterile gauze dressing supplemented with an Ace wrap
Overall Study STARTED	137	135
Overall Study COMPLETED	134	129
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications

Baseline characteristics by cohort

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap	Total n=263 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 13 • n=47 Participants	64 years STANDARD_DEVIATION 11 • n=55 Participants	65 years STANDARD_DEVIATION 12 • n=102 Participants
Sex: Female, Male Female	40 Participants n=47 Participants	42 Participants n=55 Participants	82 Participants n=102 Participants
Sex: Female, Male Male	94 Participants n=47 Participants	87 Participants n=55 Participants	181 Participants n=102 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=47 Participants	1 Participants n=55 Participants	3 Participants n=102 Participants
Race (NIH/OMB) Asian	0 Participants n=47 Participants	5 Participants n=55 Participants	5 Participants n=102 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants	0 Participants n=55 Participants	0 Participants n=102 Participants
Race (NIH/OMB) Black or African American	42 Participants n=47 Participants	37 Participants n=55 Participants	79 Participants n=102 Participants
Race (NIH/OMB) White	86 Participants n=47 Participants	85 Participants n=55 Participants	171 Participants n=102 Participants
Race (NIH/OMB) More than one race	1 Participants n=47 Participants	0 Participants n=55 Participants	1 Participants n=102 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=47 Participants	1 Participants n=55 Participants	4 Participants n=102 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=47 Participants	13 Participants n=55 Participants	21 Participants n=102 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	117 Participants n=47 Participants	103 Participants n=55 Participants	220 Participants n=102 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=47 Participants	13 Participants n=55 Participants	22 Participants n=102 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

Presence of any of the following post-procedure:

• Dehiscence (skin or fascia)
• Seroma
• Lymph leak
• Infection (superficial or deep, using CDC Surgical Site Infection criteria)
• Hematoma
• Ischemia
• Necrosis

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
Overall Rate of Wound Complications	26 Participants	31 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

index LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complication

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
Length of Stay (LOS)	10 Length of stay in days Standard Deviation 7.6	9.6 Length of stay in days Standard Deviation 6.5

SECONDARY outcome

Timeframe: 30 days post procedure

Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
30-day Return to Operating Room (ROR)	5 Participants	11 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Rehospitalization for wound complication within 30 days

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
30-day Hospital Readmissions	12 Participants	15 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Individual rates of the incidence of skin dehiscence

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
Incidence of Skin Dehiscence	15 Participants	11 Participants

SECONDARY outcome

Timeframe: 30 Days

Individual incidence rate of fascial dehiscence

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
Incidence of Fascial Dehiscence	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Individual incidence of superficial skin infection

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
Incidence of Superficial Skin Infection	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Individual incidence of deep skin infection

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
Incidence of Deep Skin Infection	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 30 Days

Individual incidence of seroma

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
Incidence of Seroma	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days

Individual Incidence of Hematoma

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
Incidence of Hematoma	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 Days

Individual incidence of Necrosis

Outcome measures

Measure	Prevena n=134 Participants PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 Participants sterile gauze dressing supplemented with an Ace wrap
Incidence of Necrosis	4 Participants	10 Participants

Adverse Events

Prevena

Serious events: 11 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard Care

Serious events: 14 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Prevena n=134 participants at risk PREVENA™ PEEL \& PLACE™ Dressing Kit	Standard Care n=129 participants at risk sterile gauze dressing supplemented with an Ace wrap
Skin and subcutaneous tissue disorders Hematoma	0.00% 0/134 • 30 days following hospitalization for amputation	0.78% 1/129 • Number of events 1 • 30 days following hospitalization for amputation
Vascular disorders Homorrhage from Operative Site	0.00% 0/134 • 30 days following hospitalization for amputation	1.6% 2/129 • Number of events 2 • 30 days following hospitalization for amputation
Gastrointestinal disorders Gastrointestinal Hemorrhage	0.75% 1/134 • Number of events 1 • 30 days following hospitalization for amputation	0.78% 1/129 • Number of events 1 • 30 days following hospitalization for amputation
Blood and lymphatic system disorders Anemia	0.75% 1/134 • Number of events 1 • 30 days following hospitalization for amputation	0.00% 0/129 • 30 days following hospitalization for amputation
Skin and subcutaneous tissue disorders Delayed Wound Healing	0.00% 0/134 • 30 days following hospitalization for amputation	1.6% 2/129 • Number of events 2 • 30 days following hospitalization for amputation
Immune system disorders Sepsis	1.5% 2/134 • Number of events 2 • 30 days following hospitalization for amputation	0.00% 0/129 • 30 days following hospitalization for amputation
Skin and subcutaneous tissue disorders Skin Dehiscence	1.5% 2/134 • Number of events 2 • 30 days following hospitalization for amputation	0.78% 1/129 • Number of events 1 • 30 days following hospitalization for amputation
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.00% 0/134 • 30 days following hospitalization for amputation	0.78% 1/129 • Number of events 1 • 30 days following hospitalization for amputation
Product Issues Loose Staple	0.75% 1/134 • Number of events 1 • 30 days following hospitalization for amputation	0.00% 0/129 • 30 days following hospitalization for amputation
Musculoskeletal and connective tissue disorders Osteomyelitis	0.75% 1/134 • Number of events 1 • 30 days following hospitalization for amputation	0.00% 0/129 • 30 days following hospitalization for amputation
Injury, poisoning and procedural complications Worsening post-procedure pain	0.00% 0/134 • 30 days following hospitalization for amputation	2.3% 3/129 • Number of events 3 • 30 days following hospitalization for amputation
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/134 • 30 days following hospitalization for amputation	0.78% 1/129 • Number of events 1 • 30 days following hospitalization for amputation
Cardiac disorders Angina	0.75% 1/134 • Number of events 1 • 30 days following hospitalization for amputation	0.00% 0/129 • 30 days following hospitalization for amputation
Respiratory, thoracic and mediastinal disorders Acute respiratory Distress	0.75% 1/134 • Number of events 1 • 30 days following hospitalization for amputation	0.00% 0/129 • 30 days following hospitalization for amputation
Skin and subcutaneous tissue disorders Soft Tissue Infection	0.75% 1/134 • Number of events 1 • 30 days following hospitalization for amputation	0.78% 1/129 • Number of events 1 • 30 days following hospitalization for amputation
Cardiac disorders STEMI	0.00% 0/134 • 30 days following hospitalization for amputation	0.78% 1/129 • Number of events 1 • 30 days following hospitalization for amputation

Other adverse events

Adverse event data not reported

Additional Information

Paul DiMuzio, MD

Thomas Jefferson University

Phone: 215-955-8304

Email: paul.dimuzio@jefferson.edu

Results disclosure agreements

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