Complication of Surgical ProcedureNCT02006511
Incisional Negative Pressure Dressing on Clean Closed Groin Incisions
A study testing Incisional Neg Pressure Wound Therapy (Prevena™) in people with Complication of Surgical Procedure, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Wound complications associated with surgical incisions range from minor to life threatening. Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications. Perigraft infections in groin wounds can be devastating. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Complication of Surgical Procedure
- What is being tested?
- Incisional Neg Pressure Wound Therapy (Prevena™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2013to 1 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or greater
- Scheduled elective vascular surgery which requires groin incision. Elective surgery is defined as planned surgery a minimum of 24 hours before the procedure.
- Meets high risk criteria according to the following rating system
- Scores at least 8 points for the following risk factors:
- MAJOR 4 points:
- BMI of <18 kg/m2 or ≥BMI 40 kg/m2 ***
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- Insulin dependent Diabetes Mellitus*
- Dialysis (hemodialysis or peritoneal dialysis)**
- INTERMEDIATE 2 points:
- Previous groin surgery
- Diabetes Mellitus not requiring insulin*
- Chronic lung disease GOLD >2
- On long-term immunosuppressive medication (>3 months at time of enrollment)
- Chronic kidney disease (defined as a GFR <30ml/min/1.73m2 for 3 months)**
- Previous lower extremity or abdominal wall radiotherapy radiotherapy
- BMI between 35 and 40***
- MINOR 1 point:
- Previous abdominal surgery
- Peripheral vascular disease
- Female gender
- Age >75 years old
- Hospitalized at least 7 days before surgery
- , , mutually exclusive, highest score should be used
- Capable of providing informed consent or has a legally authorized representative (LAR) if unable to provide informed consent
- Willing and able to adhere to the study visit schedule
Who cannot join
- Subjects meeting any of the following criteria may not be enrolled in the study:
- Is pregnant
- Has a systemic infection at the time of surgery (ie bacteremia)
- Has a remote body site infection at the time of surgery (ie UTI)
- Has a known allergy or hypersensitivity to silver, adhesive, or dressing material
- Has a requirement for competing therapy (ie open negative pressure wound therapy)
- Is simultaneously participating in another interventional trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Incisional Negative Pressure Dressing on Clean Closed Groin Incisions in High Risk Patients
Wound complications associated with surgical incisions range from minor to life threatening. Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications. Perigraft infections in groin wounds can be devastating. Even superficial wounds can progress to deep wounds resulting in graft infection, need for explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had favorable results on closed wounds in trauma populations. Similarly, negative pressure wound therapy has had positive benefits in closed incisions such as sternal wounds following cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to allow easier application of negative pressure therapy to closed wounds. Application of the PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure (VAC®) therapy with the added benefits of protecting the wound from contamination and bolstering the wound edges for better approximation and consequently better aesthetic outcome. However, no comparison between negative pressure therapy as a dressing and standard wound dressings exists.
The purpose of this study is to assess the efficacy and safety of topical negative pressure therapy application with Prevena™ versus standard of care wound therapy on closed groin incisions in high risk patients undergoing vascular surgery.
- Conditions
- Complication of Surgical Procedure
- Being tested
- Incisional Neg Pressure Wound Therapy (Prevena™), Standard of Care wound therapy
- Keywords
- incisional negative pressure wound therapy, groin incision, incisional VAC, Prevena, groin wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional Neg Pressure Wound Therapy (Prevena™)Device
Negative pressure wound therapy dressing applied over closed surgical incision
Standard of Care wound therapyOther
Gauze type dressing.
| Study group | Role | What they receive |
|---|---|---|
| Incisional Neg Pressure Wound Therapy | Experimental | Incisional negative pressure wound therapy dressings applied to the surgical site Receives: Device: Incisional Neg Pressure Wound Therapy (Prevena™) |
| Standard of care wound dressing | Active comparator | Standard of care wound dressing of gauze and tape or the equivalent applied to the surgical site Receives: Other: Standard of Care wound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep wound infection
Measured: within 30 postoperative days
Secondary outcomes (2)
Superficial Wound Infection
Cellulitis or other superficial infection of the wound or tissue immediately surrounding the wound
Measured: within 30 postoperative days
Wound dehiscence
Spontaneous opening of a previously closed surgical wound
Measured: within 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study start1 Dec 2013
- Primary completion1 Dec 2014
- Study completion1 Dec 2014
Why it stopped: The study was never performed and closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Bluebond-Langer, MD, Principal investigator, University of Maryland, School of Medicine, Dept of Surgery, Division of Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006511
- Sponsor's protocol ID
- HP-00057511
- Status last verified
- Dec 2017
- First submitted
- 13 Nov 2013
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Negative Pressure Dressing on Clean Closed Groin Incisions in High Risk Patients
- ClinicalTrials.gov ID
- NCT02006511
- Acronym / sponsor ID
- HP-00057511
- Conditions
- Complication of Surgical Procedure
- Keywords
- incisional negative pressure wound therapy, groin incision, incisional VAC, Prevena, groin wound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never performed and closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 1 Dec 2014 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Wound complications associated with surgical incisions range from minor to life threatening. Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications. Perigraft infections in groin wounds can be devastating. Even superficial wounds can progress to deep wounds resulting in graft infection, need for explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had favorable results on closed wounds in trauma populations. Similarly, negative pressure wound therapy has had positive benefits in closed incisions such as sternal wounds following cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to allow easier application of negative pressure therapy to closed wounds. Application of the PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure (VAC®) therapy with the added benefits of protecting the wound from contamination and bolstering the wound edges for better approximation and consequently better aesthetic outcome. However, no comparison between negative pressure therapy as a dressing and standard wound dressings exists.
The purpose of this study is to assess the efficacy and safety of topical negative pressure therapy application with Prevena™ versus standard of care wound therapy on closed groin incisions in high risk patients undergoing vascular surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incisional Neg Pressure Wound Therapy | Experimental | Device: Incisional Neg Pressure Wound Therapy (Prevena™)Incisional negative pressure wound therapy dressings applied to the surgical site |
| Standard of care wound dressing | Active comparator | Other: Standard of Care wound therapyStandard of care wound dressing of gauze and tape or the equivalent applied to the surgical site |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Male or female 18 years of age or greater
- Scheduled elective vascular surgery which requires groin incision. Elective surgery is defined as planned surgery a minimum of 24 hours before the procedure.
- Meets high risk criteria according to the following rating system
- Scores at least 8 points for the following risk factors:
- BMI of <18 kg/m2 or ≥BMI 40 kg/m2 ***
Key exclusion criteria (7 listed)
- Subjects meeting any of the following criteria may not be enrolled in the study:
- Is pregnant
- Has a systemic infection at the time of surgery (ie bacteremia)
- Has a remote body site infection at the time of surgery (ie UTI)
- Has a known allergy or hypersensitivity to silver, adhesive, or dressing material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incisional Neg Pressure Wound Therapy (Prevena™)Negative pressure wound therapy dressing applied over closed surgical incision | Device | Incisional Neg Pressure Wound Therapy |
| Standard of Care wound therapyGauze type dressing. | Other | Standard of care wound dressing |
Primary outcome
Deep wound infection
Time frame: within 30 postoperative days
2 secondary outcomes
Superficial Wound Infection
Time frame: within 30 postoperative days
Wound dehiscence
Time frame: within 30 postoperative days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Bluebond-Langer, MD principal investigator
University of Maryland, School of Medicine, Dept of Surgery, Division of Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisional Neg Pressure Wound Therapy (Prevena™) in people with Complication of Surgical Procedure, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep wound infection (time frame: within 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.