Wound InfectionNCT02836990
Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery
A study testing Prevena Incision Management System and Dermabond in people with Wound Infection, run by State University of New York at Buffalo at 2 sites in United States.
Trial summary
This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection
- What is being tested?
- Prevena Incision Management System and Dermabond
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to Sep 2019
- 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
- In need of elective vascular procedure requiring ≥8 cm groin incision.
- Able to provide consent
- Able to care for wound or have support person to complete wound care
- Willing to comply with follow-up
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaleida Health, Gates Vascular Institute
Buffalo, New York, 14203
State University of New York at Buffalo
Buffalo, New York, 14203
About this study
Official title: Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery
This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.
Read the detailed description
Dermabond and the Prevena Incision Management System are both FDA approved wound care products. Prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. Dermabond is a surgical glue which holds the wound together to prevents infection. Prevena is more expensive to apply. However, the hypothesis is that the Prevena System will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.
- Conditions
- Wound Infection
- Being tested
- Prevena Incision Management System, Dermabond
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena Incision Management SystemDevice
Also called Prevena
A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections
DermabondDevice
A surgical skin adhesive used to prevent surgical wound infections
| Study group | Role | What they receive |
|---|---|---|
| Prevena | Active comparator | Prevena Incision Management System for vascular surgical groin wounds Receives: Device: Prevena Incision Management System |
| Dermabond | Active comparator | Dermabond for vascular surgical groin wounds Receives: Device: Dermabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond
The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision).
Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection.
Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.
Measured: 30 days
Secondary outcomes (2)
Cost of Care
Comparison of cost of treatment between the two arms
Measured: 30 days
Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection
Physician office visits for diagnosis of Infection or visiting nurse visits for diagnosis of infection ONLY were assessed.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2019
- Study completionSep 2019
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.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- KCI USA, Inc
- Responsible party
- Principal investigator, Linda Harris, State University of New York at Buffalo
- Investigators
- Linda Harris, MD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836990
- Sponsor's protocol ID
- Prevena
- Status last verified
- Dec 2020
- First submitted
- 11 Jul 2016
- Last updated
- 28 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ploeg AJ, Lardenoye JW, Peeters MP, Hamming JF, Breslau PJ. Wound complications at the groin after peripheral arterial surgery sparing the lymphatic tissue: a double-blind randomized clinical trial. Am J Surg. 2009 Jun;197(6):747-51. doi: 10.1016/j.amjsurg.2008.04.014. Epub 2008 Oct 17.
PubMed 18929355Lee ES, Santilli SM, Olson MM, Kuskowski MA, Lee JT. Wound infection after infrainguinal bypass operations: multivariate analysis of putative risk factors. Surg Infect (Larchmt). 2000 Winter;1(4):257-63. doi: 10.1089/109629600750067183.
PubMed 12594881Lawlor DK, Derose G, Harris KA, Lovell MB, Novick TV, Forbes TL. The role of platelet-rich plasma in inguinal wound healing in vascular surgery patients. Vasc Endovascular Surg. 2011 Apr;45(3):241-5. doi: 10.1177/1538574411399157.
PubMed 21478245Exton RJ, Galland RB. Major groin complications following the use of synthetic grafts. Eur J Vasc Endovasc Surg. 2007 Aug;34(2):188-90. doi: 10.1016/j.ejvs.2007.03.012. Epub 2007 May 18.
PubMed 17512763Engin C, Posacioglu H, Ayik F, Apaydin AZ. Management of vascular infection in the groin. Tex Heart Inst J. 2005;32(4):529-34.
PubMed 16429897Bandyk DF. Vascular surgical site infection: risk factors and preventive measures. Semin Vasc Surg. 2008 Sep;21(3):119-23. doi: 10.1053/j.semvascsurg.2008.05.008.
PubMed 18774446Swinnen J, Chao A, Tiwari A, Crozier J, Vicaretti M, Fletcher J. Vertical or transverse incisions for access to the femoral artery: a randomized control study. Ann Vasc Surg. 2010 Apr;24(3):336-41. doi: 10.1016/j.avsg.2009.07.020. Epub 2009 Dec 4.
PubMed 19962270Dosluoglu HH, Loghmanee C, Lall P, Cherr GS, Harris LM, Dryjski ML. Management of early (<30 day) vascular groin infections using vacuum-assisted closure alone without muscle flap coverage in a consecutive patient series. J Vasc Surg. 2010 May;51(5):1160-6. doi: 10.1016/j.jvs.2009.11.053. Epub 2010 Mar 31.
PubMed 20356703Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
PubMed 10219875Easterlin B, Bromberg W, Linscott J. A Novel Technique of Vacuum-assisted Wound Closure That Functions as a Delayed Primary Closure. Wounds. 2007 Dec;19(12):331-3.
PubMed 25942681de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
PubMed 19398246Weir G. The use of a surgical incision management system on vascular surgery incisions: a pilot study. Int Wound J. 2014 Jun;11 Suppl 1(Suppl 1):10-2. doi: 10.1111/iwj.12261.
PubMed 24851730Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9.
PubMed 23312938Bruns TB, Worthington JM. Using tissue adhesive for wound repair: a practical guide to dermabond. Am Fam Physician. 2000 Mar 1;61(5):1383-8.
PubMed 10735344Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
PubMed 41159585
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery
- ClinicalTrials.gov ID
- NCT02836990
- Acronym / sponsor ID
- Prevena
- Conditions
- Wound Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- KCI USA, Inc
- Study start
- Jul 2016
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Posted 28 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.
Detailed description
Dermabond and the Prevena Incision Management System are both FDA approved wound care products. Prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. Dermabond is a surgical glue which holds the wound together to prevents infection. Prevena is more expensive to apply. However, the hypothesis is that the Prevena System will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevena | Active comparator | Device: Prevena Incision Management SystemPrevena Incision Management System for vascular surgical groin wounds |
| Dermabond | Active comparator | Device: DermabondDermabond for vascular surgical groin wounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In need of elective vascular procedure requiring ≥8 cm groin incision.
- Able to provide consent
- Able to care for wound or have support person to complete wound care
- Willing to comply with follow-up
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Prevena Incision Management SystemAlso: PrevenaA negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections | Device | Prevena |
| DermabondA surgical skin adhesive used to prevent surgical wound infections | Device | Dermabond |
Primary outcome
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond
Time frame: 30 days
The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision). Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection. Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.
2 secondary outcomes
Cost of Care
Time frame: 30 days
Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18929355Ploeg AJ, Lardenoye JW, Peeters MP, Hamming JF, Breslau PJ. Wound complications at the groin after peripheral arterial surgery sparing the lymphatic tissue: a double-blind randomized clinical trial. Am J Surg. 2009 Jun;197(6):747-51. doi: 10.1016/j.amjsurg.2008.04.014. Epub 2008 Oct 17.
- Background: PubMed 12594881Lee ES, Santilli SM, Olson MM, Kuskowski MA, Lee JT. Wound infection after infrainguinal bypass operations: multivariate analysis of putative risk factors. Surg Infect (Larchmt). 2000 Winter;1(4):257-63. doi: 10.1089/109629600750067183.
- Background: PubMed 21478245Lawlor DK, Derose G, Harris KA, Lovell MB, Novick TV, Forbes TL. The role of platelet-rich plasma in inguinal wound healing in vascular surgery patients. Vasc Endovascular Surg. 2011 Apr;45(3):241-5. doi: 10.1177/1538574411399157.
- Background: PubMed 17512763Exton RJ, Galland RB. Major groin complications following the use of synthetic grafts. Eur J Vasc Endovasc Surg. 2007 Aug;34(2):188-90. doi: 10.1016/j.ejvs.2007.03.012. Epub 2007 May 18.
- Background: PubMed 16429897Engin C, Posacioglu H, Ayik F, Apaydin AZ. Management of vascular infection in the groin. Tex Heart Inst J. 2005;32(4):529-34.
- Background: PubMed 18774446Bandyk DF. Vascular surgical site infection: risk factors and preventive measures. Semin Vasc Surg. 2008 Sep;21(3):119-23. doi: 10.1053/j.semvascsurg.2008.05.008.
- Background: PubMed 19962270Swinnen J, Chao A, Tiwari A, Crozier J, Vicaretti M, Fletcher J. Vertical or transverse incisions for access to the femoral artery: a randomized control study. Ann Vasc Surg. 2010 Apr;24(3):336-41. doi: 10.1016/j.avsg.2009.07.020. Epub 2009 Dec 4.
- Background: PubMed 20356703Dosluoglu HH, Loghmanee C, Lall P, Cherr GS, Harris LM, Dryjski ML. Management of early (<30 day) vascular groin infections using vacuum-assisted closure alone without muscle flap coverage in a consecutive patient series. J Vasc Surg. 2010 May;51(5):1160-6. doi: 10.1016/j.jvs.2009.11.053. Epub 2010 Mar 31.
- Background: PubMed 10219875Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
- Background: PubMed 25942681Easterlin B, Bromberg W, Linscott J. A Novel Technique of Vacuum-assisted Wound Closure That Functions as a Delayed Primary Closure. Wounds. 2007 Dec;19(12):331-3.
- Background: PubMed 19398246de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
- Background: PubMed 24851730Weir G. The use of a surgical incision management system on vascular surgery incisions: a pilot study. Int Wound J. 2014 Jun;11 Suppl 1(Suppl 1):10-2. doi: 10.1111/iwj.12261.
- Prevena TM Incision Management SystemLink provided by the sponsor.
- 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.
Linda Harris, MD principal investigator
State University of New York at Buffalo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena Incision Management System and Dermabond in people with Wound Infection, run by State University of New York at Buffalo at 2 sites 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 1 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: finished, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 28 Dec 2020). 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?
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836990, which also lists 16 linked publications.
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 28 Dec 2020.