An interventional study of PREVENA™ PEEL & PLACE™ Dressing Kit in Amputation, Amputation; Postoperative, Sequelae and Wound Dehiscence, sponsored by Thomas Jefferson University. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Other
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.
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
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's enrollment of 272 is above the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Thomas Jefferson University is the lead sponsor of 393 studies on the registry; 70 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PREVENA™ PEEL \& PLACE™ Dressing Kit
Device: PREVENA™ PEEL & PLACE™ Dressing Kit
sterile gauze dressing supplemented with an Ace wrap
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).
Overall Rate of Wound Complications
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
Time frame: 30 days post procedure
Length of Stay (LOS)
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
Time frame: 30 days post procedure
30-day Return to Operating Room (ROR)
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
Time frame: 30 days post procedure
30-day Hospital Readmissions
Rehospitalization for wound complication within 30 days
Time frame: 30 days post procedure
Incidence of Skin Dehiscence
Individual rates of the incidence of skin dehiscence
Time frame: 30 days post procedure
Incidence of Fascial Dehiscence
Individual incidence rate of fascial dehiscence
Time frame: 30 Days
Incidence of Superficial Skin Infection
Individual incidence of superficial skin infection
Time frame: 30 days
Incidence of Deep Skin Infection
Individual incidence of deep skin infection
Time frame: 30 days
Incidence of Seroma
Individual incidence of seroma
Time frame: 30 Days
Incidence of Hematoma
Individual Incidence of Hematoma
Time frame: 30 days
Incidence of Necrosis
Individual incidence of Necrosis
Time frame: 30 Days
| Milestone | Prevena | Standard Care |
|---|---|---|
| Started | 137 | 135 |
| Completed | 134 | 129 |
| Not completed | 3 | 6 |
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
| Participants | Prevena | Standard Care |
|---|---|---|
| Overall Rate of Wound Complications | 26 | 31 |
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
| Length of stay in days | Prevena | Standard Care |
|---|---|---|
| Length of Stay (LOS) | 10 ± 7.6 | 9.6 ± 6.5 |
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
| Participants | Prevena | Standard Care |
|---|---|---|
| 30-day Return to Operating Room (ROR) | 5 | 11 |
Rehospitalization for wound complication within 30 days
| Participants | Prevena | Standard Care |
|---|---|---|
| 30-day Hospital Readmissions | 12 | 15 |
Individual rates of the incidence of skin dehiscence
| Participants | Prevena | Standard Care |
|---|---|---|
| Incidence of Skin Dehiscence | 15 | 11 |
Individual incidence rate of fascial dehiscence
| Participants | Prevena | Standard Care |
|---|---|---|
| Incidence of Fascial Dehiscence | 2 | 2 |
Individual incidence of superficial skin infection
| Participants | Prevena | Standard Care |
|---|---|---|
| Incidence of Superficial Skin Infection | 2 | 2 |
Individual incidence of deep skin infection
| Participants | Prevena | Standard Care |
|---|---|---|
| Incidence of Deep Skin Infection | 5 | 4 |
Individual incidence of seroma
| Participants | Prevena | Standard Care |
|---|---|---|
| Incidence of Seroma | 1 | 1 |
Individual Incidence of Hematoma
| Participants | Prevena | Standard Care |
|---|---|---|
| Incidence of Hematoma | 2 | 3 |
Individual incidence of Necrosis
| Participants | Prevena | Standard Care |
|---|---|---|
| Incidence of Necrosis | 4 | 10 |
Collected over 30 days following hospitalization for amputation. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prevena | 1/134 (0.7%) | 11/134 (8.2%) | 0/134 (0%) |
| Standard Care | 1/129 (0.8%) | 14/129 (10.9%) | 0/129 (0%) |
| Event | Prevena | Standard Care |
|---|---|---|
| Worsening post-procedure painInjury, poisoning and procedural complications | 0/134 | 3/129 |
| Delayed Wound HealingSkin and subcutaneous tissue disorders | 0/134 | 2/129 |
| Homorrhage from Operative SiteVascular disorders | 0/134 | 2/129 |
| SepsisImmune system disorders | 2/134 | 0/129 |
| Skin DehiscenceSkin and subcutaneous tissue disorders | 2/134 | 1/129 |
| Gastrointestinal HemorrhageGastrointestinal disorders | 1/134 | 1/129 |
| HematomaSkin and subcutaneous tissue disorders | 0/134 | 1/129 |
| Interstitial Lung DiseaseRespiratory, thoracic and mediastinal disorders | 0/134 | 1/129 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/134 | 1/129 |
| Soft Tissue InfectionSkin and subcutaneous tissue disorders | 1/134 | 1/129 |
| Age, Continuous(years) | Prevena | Standard Care | Total |
|---|---|---|---|
| Mean | 65 ± 13 | 64 ± 11 | 65 ± 12 |
| Sex: Female, Male(Participants) | Prevena | Standard Care | Total |
|---|---|---|---|
| Female | 40 | 42 | 82 |
| Male | 94 | 87 | 181 |
| Race (NIH/OMB)(Participants) | Prevena | Standard Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 0 | 5 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 42 | 37 | 79 |
| White | 86 | 85 | 171 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Prevena | Standard Care | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 13 | 21 |
| Not Hispanic or Latino | 117 | 103 | 220 |
| Unknown or Not Reported | 9 | 13 | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.