Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair
NCT ID: NCT04455724
Last Updated: 2024-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2020-12-14
2024-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Negative Pressure Incisional Wound Therapy
A PREVENA™ PEEL \& PLACE™ system kit will be applied to the surgical wound and assembled in the operating room following closure by primary intent. The system will be set for a negative pressure of -125mmHg. The dressing will be left in place for 7 days post-operation, during which the patient may be discharged from hospital. The dressing will only be removed or changed if the treating physician has suspicion of one of the complications included in the primary composite outcome or is planning re-intervention on the surgical site.
Negative pressure incisional wound therapy
A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.
Standard sterile dressing
A sterile island dressing will be applied to the surgical wound in the operating room following closure by primary intent, which will be removed on post-operative day 2 and left open to air unless there is ongoing discharge.
Standard sterile dressing
A standard, sterile island dressing
Interventions
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Negative pressure incisional wound therapy
A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.
Standard sterile dressing
A standard, sterile island dressing
Eligibility Criteria
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Inclusion Criteria
2. have one or more of the following risk factors for post-operative surgical site complications:
1. Body Mass Index (BMI) greater than or equal to 30
2. diagnosis of diabetes mellitus (either type I or II)
3. previous history of hernia recurrence
4. active smoker
5. presence of colostomy or ileostomy
6. age greater than 64
7. chronic obstructive pulmonary disease
8. chronic kidney disease
9. clinically immunocompromised.
Exclusion Criteria
2. if the patient has a sensitivity to silver.
18 Years
ALL
Yes
Sponsors
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McMaster University
OTHER
Responsible Party
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Principal Investigators
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Christopher E Blewett, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Niagara Health St. Catharines Site
St. Catharines, Ontario, Canada
Countries
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References
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Lindmark M, Strigard K, Lowenmark T, Dahlstrand U, Gunnarsson U. Risk Factors for Surgical Complications in Ventral Hernia Repair. World J Surg. 2018 Nov;42(11):3528-3536. doi: 10.1007/s00268-018-4642-6.
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Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.
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Rodriguez-Unda N, Soares KC, Azoury SC, Baltodano PA, Hicks CW, Burce KK, Cornell P, Cooney CM, Eckhauser FE. Negative-Pressure Wound Therapy in the Management of High-Grade Ventral Hernia Repairs. J Gastrointest Surg. 2015 Nov;19(11):2054-61. doi: 10.1007/s11605-015-2894-0. Epub 2015 Aug 4.
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Yu L, Kronen RJ, Simon LE, Stoll CRT, Colditz GA, Tuuli MG. Prophylactic negative-pressure wound therapy after cesarean is associated with reduced risk of surgical site infection: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Feb;218(2):200-210.e1. doi: 10.1016/j.ajog.2017.09.017. Epub 2017 Sep 23.
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Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, Pauser J, Gelse K, Brem MH. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. Int Orthop. 2012 Apr;36(4):719-22. doi: 10.1007/s00264-011-1321-8. Epub 2011 Jul 15.
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Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.
Grauhan O, Navasardyan A, Tutkun B, Hennig F, Muller P, Hummel M, Hetzer R. Effect of surgical incision management on wound infections in a poststernotomy patient population. Int Wound J. 2014 Jun;11 Suppl 1(Suppl 1):6-9. doi: 10.1111/iwj.12294.
Other Identifiers
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8183
Identifier Type: -
Identifier Source: org_study_id
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