Amputation, Amputation; Postoperative, Sequelae, Lymph Leakage, Seroma, Wound Dehiscence, Wound Infection, Surgical
Conditions
Brief summary
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.
Detailed description
This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL & PLACE™ Dressing Kit) on incidence of post-operative wound complications in patients undergoing above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately five (5) participating sites will be randomized to receive either the Prevena dressing or a standard care dressing. The incision will be assessed for complications at post-op day 5 or day 6 and at approximately 30 days after discharge. The primary outcome of this study is reported wound complications, including dehiscence (opening of the incision), seroma, lymph leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood supply), and necrosis (tissue death) A major complication is defined as any wound complication requiring intravenous or oral antibiotics, reoperation and/or hospital readmission. All data (demographics, medical history, and clinical outcomes) will be collected via medical record review
Interventions
DEVICEPREVENA™ PEEL & PLACE™ Dressing Kit
In combination with a negative pressure pump (V.A.C. ® Therapy Unit, KCI USA, Inc.), the Prevena dressing is designed to provide negative pressure wound therapy (NPWT) over surgical incisions (incisional NPWT).
Sponsors
Thomas Jefferson University
Acelity
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female adults 18 years or older 2. Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations) 3. Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations) 4. Informed Consent signed by patient
Exclusion criteria
1. Minors under 18 years 2. Women who are pregnant or breastfeeding 3. Patients having BOTH legs amputated 4. Patients with sensitivity to silver 5. Unwilling or unable to provide informed consent 6. Inability to comply with planned study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Rate of Wound Complications | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (LOS) | 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 |
| 30-day Return to Operating Room (ROR) | 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 |
| 30-day Hospital Readmissions | 30 days post procedure | Rehospitalization for wound complication within 30 days |
| Incidence of Skin Dehiscence | 30 days post procedure | Individual rates of the incidence of skin dehiscence |
| Incidence of Fascial Dehiscence | 30 Days | Individual incidence rate of fascial dehiscence |
| Incidence of Superficial Skin Infection | 30 days | Individual incidence of superficial skin infection |
| Incidence of Deep Skin Infection | 30 days | Individual incidence of deep skin infection |
| Incidence of Seroma | 30 Days | Individual incidence of seroma |
| Incidence of Hematoma | 30 days | Individual Incidence of Hematoma |
| Incidence of Necrosis | 30 Days | Individual incidence of Necrosis |
Countries
Italy, United States
Contacts
PRINCIPAL_INVESTIGATORPaul DiMuzio, MD
Thomas Jefferson University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 220 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 79 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 171 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 134 | 1 / 129 |
| other Total, other adverse events | 0 / 134 | 0 / 129 |
| serious Total, serious adverse events | 11 / 134 | 14 / 129 |
Outcome results
None listed