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| Name | Class |
|---|---|
| KCI USA, Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevena | Active Comparator | Prevena Incision Management System for vascular surgical groin wounds |
|
| Dermabond | Active Comparator | Dermabond for vascular surgical groin wounds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena Incision Management System | Device | A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of Care | Comparison of cost of treatment between the two arms | 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. |
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Inclusion Criteria:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Linda Harris, MD | State University of New York at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaleida Health, Gates Vascular Institute | Buffalo | New York | 14203 | United States | ||
| State University of New York at Buffalo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18929355 | Background | 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. | |
| 12594881 | Background |
| Label | URL |
|---|---|
| Prevena TM Incision Management System | View source |
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Participants were recruited from UBMD Vascular Surgery Office and were consented at the time of surgery at Buffalo General Medical Center between 2016 and 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevena | Prevena Incision Management System for vascular surgical groin wounds Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections |
| FG001 | Dermabond | Dermabond for vascular surgical groin wounds Dermabond: A surgical skin adhesive used to prevent surgical wound infections |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Several patients randomized did not receive the randomized treatment based on physician decision, and were excluded from analysis as actual treatment rather than intent to treat was assessed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevena | Prevena Incision Management System for vascular surgical groin wounds Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections |
| BG001 | Dermabond |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 30 days |
|
40 days from time of surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prevena | Prevena Incision Management System for vascular surgical groin wounds Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reoperation for groin complication | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Linda Harris | University at Buffalo, SUNY | 7168594207 | lmharris@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 17, 2015 | Feb 18, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2017 | Dec 23, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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|
| Dermabond | Device | A surgical skin adhesive used to prevent surgical wound infections |
|
| 30 days |
| Buffalo |
| New York |
| 14203 |
| United States |
| Lee 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. |
| 21478245 | Background | Lawlor 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. |
| 17512763 | Background | Exton 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. |
| 16429897 | Background | Engin C, Posacioglu H, Ayik F, Apaydin AZ. Management of vascular infection in the groin. Tex Heart Inst J. 2005;32(4):529-34. |
| 18774446 | Background | Bandyk 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. |
| 19962270 | Background | Swinnen 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. |
| 20356703 | Background | Dosluoglu 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. |
| 10219875 | Background | Mangram 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. |
| 25942681 | Background | Easterlin 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. |
| 19398246 | Background | de 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. |
| 24851730 | Background | Weir 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. |
| 23312938 | Background | Matatov 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. |
| 10735344 | Background | Bruns TB, Worthington JM. Using tissue adhesive for wound repair: a practical guide to dermabond. Am Fam Physician. 2000 Mar 1;61(5):1383-8. |
| 41159585 | Derived | Correia 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. |
| 40260835 | Derived | Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2. |
Dermabond for vascular surgical groin wounds Dermabond: A surgical skin adhesive used to prevent surgical wound infections |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Prevena Incision Management System for vascular surgical groin wounds Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections |
| OG001 | Dermabond | Dermabond for vascular surgical groin wounds Dermabond: A surgical skin adhesive used to prevent surgical wound infections |
|
|
| Secondary | Cost of Care | Comparison of cost of treatment between the two arms | not analyzed as the primary outcome did not demonstrate improved outcomes, and the device being tested, wound vacuum, was more expensive. Had outcomes clinically been improved, financial assessment would have determined whether cost of infection outweighed cost of device. | Posted | 30 days |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 46 |
| 3 |
| 46 |
| 0 |
| 46 |
| EG001 | Dermabond | Dermabond for vascular surgical groin wounds Dermabond: A surgical skin adhesive used to prevent surgical wound infections | 0 | 55 | 2 | 55 | 0 | 55 |
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