Wound Infection, SurgicalSAVIORNCT02461433
Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
A study testing Prevena and Standard Dressing in people with Wound Infection, Surgical and Obesity, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection, Surgical, Obesity, Postoperative Complications
- What is being tested?
- Prevena and Standard Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site.
- Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes.
- Patient with BMI≥ 30 at the time of surgery
- Patient agrees to return for all required clinical follow up for the study.
Who cannot join
- Known allergic reaction to acrylic adhesives or silver.
- Known history of intolerance to any component of Prevena Incision Management System TM.
- Very fragile skin around incision site.
- Bleeding disorder or refuses blood transfusion.
- Malignancy or other condition limiting life expectancy to <5 years.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutes
Baltimore, Maryland, 21287
About this study
Official title: The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.
Read the detailed description
In an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided contained controlled wound irrigation without bacterial aerosolization. A newer customizable subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been released a few months ago. The new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available VAC machines. The versatility and the comparability to older models of Prevena Peel and Place TM have not been tested to this date.
The investigators believe that a randomized clinical trial evaluating the use of the Prevena Incision Management System TM for homecare and the use of Prevena Peel and Place TM for inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative management of surgical incisions.
- Being tested
- Prevena, Standard Dressing
- Keywords
- Obesity, Obese, surgical site infection, closed incisions, negative pressure therapy
- Medical subject headings
- Surgical Wound Infection, Obesity, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevenaDevice
Prevena Incision Management system
Standard DressingDevice
This involves standard of care dressing including but not limited to gauze.
| Study group | Role | What they receive |
|---|---|---|
| Prevena | Experimental | After surgery this group will receive the Prevena device (negative pressure wound therapy). Receives: Device: Prevena |
| Standard dressing | Active comparator | After surgery this group will receive standard of care dressings on their surgical wound. Receives: Device: Standard Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines
The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery
Measured: Up to 7 days postop
Secondary outcomes (10)
Other Wound Complications (Aggregate)
Dehiscence, seroma and hematoma. Reported as number of aggregate events.
Measured: Up to 14 days postop
Skin Bacterial Count as Assessed by Microbacterial Count
Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count
Measured: Up to 7 days postop
Physical Function as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Measured: Up to 14 days postop
Readmissions
Readmission events for the patients.
Measured: Up to 30 days postop
Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Measured: Up to 14 days postop
Social Functioning as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Measured: Up to 14 days postop
Energy / Fatigue as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Measured: Up to 14 days postop
Emotional Well Being as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Measured: Up to 14 days postop
Pain as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Measured: Up to 14 days postop
General Health as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Measured: Up to 14 days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Sponsor pulled funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound Infection, SurgicalStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Responsible party
- Sponsor
- Investigators
- Kimberley Steele, MD, PHD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461433
- Sponsor's protocol ID
- IRB00030337
- Acronym
- SAVIOR
- Status last verified
- Feb 2019
- First submitted
- 1 Jun 2015
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
- ClinicalTrials.gov ID
- NCT02461433
- Acronym / sponsor ID
- SAVIOR / IRB00030337
- Keywords
- Obesity, Obese, surgical site infection, closed incisions, negative pressure therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor pulled funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Study start
- Jun 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 12 Feb 2018
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 determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.
Detailed description
In an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided contained controlled wound irrigation without bacterial aerosolization. A newer customizable subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been released a few months ago. The new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available VAC machines. The versatility and the comparability to older models of Prevena Peel and Place TM have not been tested to this date.
The investigators believe that a randomized clinical trial evaluating the use of the Prevena Incision Management System TM for homecare and the use of Prevena Peel and Place TM for inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative management of surgical incisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevena | Experimental | Device: PrevenaAfter surgery this group will receive the Prevena device (negative pressure wound therapy). |
| Standard dressing | Active comparator | Device: Standard DressingAfter surgery this group will receive standard of care dressings on their surgical wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site.
- Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes.
- Patient with BMI≥ 30 at the time of surgery
- Patient agrees to return for all required clinical follow up for the study.
Key exclusion criteria (6 listed)
- Known allergic reaction to acrylic adhesives or silver.
- Known history of intolerance to any component of Prevena Incision Management System TM.
- Very fragile skin around incision site.
- Bleeding disorder or refuses blood transfusion.
- Malignancy or other condition limiting life expectancy to <5 years.
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 |
|---|---|---|
| PrevenaPrevena Incision Management system | Device | Prevena |
| Standard DressingThis involves standard of care dressing including but not limited to gauze. | Device | Standard dressing |
Primary outcome
Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines
Time frame: Up to 7 days postop
The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery
10 secondary outcomes
Other Wound Complications (Aggregate)
Time frame: Up to 14 days postop
Skin Bacterial Count as Assessed by Microbacterial Count
Time frame: Up to 7 days postop
Physical Function as Assessed by Short Form Survey (SF) 36
Time frame: Up to 14 days postop
Readmissions
Time frame: Up to 30 days postop
Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36
Time frame: Up to 14 days postop
Social Functioning as Assessed by Short Form Survey (SF) 36
Time frame: Up to 14 days postop
Energy / Fatigue as Assessed by Short Form Survey (SF) 36
Time frame: Up to 14 days postop
Emotional Well Being as Assessed by Short Form Survey (SF) 36
Time frame: Up to 14 days postop
Pain as Assessed by Short Form Survey (SF) 36
Time frame: Up to 14 days postop
General Health as Assessed by Short Form Survey (SF) 36
Time frame: Up to 14 days postop
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kimberley Steele, MD, PHD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena and Standard Dressing in people with Wound Infection, Surgical and Obesity, run by Johns Hopkins 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 6 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: stopped early, as of the sponsor's last update on 26 Feb 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?
Yes. Results are posted in the registry (first posted 12 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines (time frame: Up to 7 days postop). 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 26 Feb 2019.