Surgical WoundNCT03250442
Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations
A study testing PrevenaTM Device and Standard Dry Dressing in people with Surgical Wound and Wound Heal, run by Georgetown University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound, Wound Heal, Amputation
- What is being tested?
- PrevenaTM Device and Standard Dry Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to Sep 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years or older to participate.
- Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA).
- Has at least one artery that feeds the closure site.
- Able to comply with clinical trial procedures and schedule.
Who cannot join
- Patients not receiving an amputation.
- The investigator/provider determines that the patient has an indication against incisional negative pressure wound therapy that would prevent them from participating.
- Surgical incision that is not completely closed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Paul Kim, DPM, 202-444-3059
Paul Kim, DPM
About this study
Official title: A Randomized Controlled Trial Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Pilot Study
The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.
Read the detailed description
Incisional negative pressure wound therapy is an approved device used for wound healing of closed surgical incisions. This research is being done because incisional negative pressure wound therapy is a new application of negative pressure wound therapy that is applied over a closed incision area instead of an open wound. Negative pressure wound therapy is commonly used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and a battery-powered device that places negative pressure on the wound. Currently, there are no trials utilizing incisional negative pressure wound therapy of closed wounds after below knee amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure wound therapy and standard dressings in patients.
- Conditions
- Surgical Wound, Wound Heal, Amputation
- Being tested
- PrevenaTM Device, Standard Dry Dressing
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevenaTM DeviceDevice
The PrevenaTM Incision Management System covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.
Standard Dry DressingOther
These are customary dry dressings.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard Dry Dressing | Other | The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization. Receives: Other: Standard Dry Dressing |
| Group B: Foam, Drape, and PrevenaTM | Active comparator | This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization. Receives: Device: PrevenaTM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of postoperative incision complications between the 2 arms
The proportion of issues that arise between the two groups after closure surgery.
Measured: 95 days
Secondary outcomes (4)
Length of hospital stay
The amount of time the patients must stay after closure surgery.
Measured: 5 days
Number of surgically related wound readmissions
The number of times patients are readmitted to the hospital for their surgical wound post-discharge.
Measured: 95 days
Medical Outcomes Study 12 Short Form Health Survey (SF-12)
Change in quality of life from the start of the study to the end.
Measured: 95 days
Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge
The percentage of closed surgical wounds that remain closed after 1, 2 and 3 months after their closure surgery.
Measured: At 1, 2, and 3 months post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Nov 2017
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Attinger, M.D., Georgetown University
- Investigators
- Christopher Attinger, MD, Principal investigator, MedStar Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250442
- Sponsor's protocol ID
- 2017-0599
- Status last verified
- Sep 2019
- First submitted
- 8 Aug 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Pilot Study
- ClinicalTrials.gov ID
- NCT03250442
- Acronym / sponsor ID
- 2017-0599
- Conditions
- Surgical Wound, Wound Heal, Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 15 Aug 2017 (actual)
- 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.
The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.
Detailed description
Incisional negative pressure wound therapy is an approved device used for wound healing of closed surgical incisions. This research is being done because incisional negative pressure wound therapy is a new application of negative pressure wound therapy that is applied over a closed incision area instead of an open wound. Negative pressure wound therapy is commonly used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and a battery-powered device that places negative pressure on the wound. Currently, there are no trials utilizing incisional negative pressure wound therapy of closed wounds after below knee amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure wound therapy and standard dressings in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard Dry Dressing | Other | Other: Standard Dry DressingThe standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization. |
| Group B: Foam, Drape, and PrevenaTM | Active comparator | Device: PrevenaTM DeviceThis arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be at least 18 years or older to participate.
- Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA).
- Has at least one artery that feeds the closure site.
- Able to comply with clinical trial procedures and schedule.
Key exclusion criteria (3 listed)
- Patients not receiving an amputation.
- The investigator/provider determines that the patient has an indication against incisional negative pressure wound therapy that would prevent them from participating.
- Surgical incision that is not completely closed.
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 |
|---|---|---|
| PrevenaTM DeviceThe PrevenaTM Incision Management System covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision. | Device | Group B: Foam, Drape, and PrevenaTM |
| Standard Dry DressingThese are customary dry dressings. | Other | Group A: Standard Dry Dressing |
Primary outcome
Proportion of postoperative incision complications between the 2 arms
Time frame: 95 days
The proportion of issues that arise between the two groups after closure surgery.
4 secondary outcomes
Length of hospital stay
Time frame: 5 days
Number of surgically related wound readmissions
Time frame: 95 days
Medical Outcomes Study 12 Short Form Health Survey (SF-12)
Time frame: 95 days
Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge
Time frame: At 1, 2, and 3 months post-hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Christopher Attinger, MD principal investigator
MedStar Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrevenaTM Device and Standard Dry Dressing in people with Surgical Wound and Wound Heal, run by Georgetown University 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Attinger, MD (202-444-8780, christopher.attinger@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of postoperative incision complications between the 2 arms (time frame: 95 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 25 Sep 2019.