Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair

NCT04455724 | Completed FDA Device

• 1 other identifier: 8183
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are testing the ability of vacuum dressings to improve wound healing for patients having large hernias surgically repaired who are at risk of having wound complications. The trial will randomly be giving some patients having this surgery the vacuum dressing and some a standard dressing and observing how their wounds heal in hospital and at follow-up appointments.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Surgical Site Complications

  Composite of incidence of surgical site infection, hematoma formation, seroma formation, wound dehiscence, hernia recurrence, and fistula formation.

  First 3 months post-operatively

Secondary Outcomes (2)

• Quality of life after surgery: survey

  3 months post-operatively

• Cost-effectiveness

  3 months post-operatively

Study Arms (2)

Negative Pressure Incisional Wound Therapy

EXPERIMENTAL

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.

Device: Negative pressure incisional wound therapy

Standard sterile dressing

ACTIVE COMPARATOR

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.

Device: Standard sterile dressing

Interventions

Negative pressure incisional wound therapy DEVICE

A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.

Negative Pressure Incisional Wound Therapy

Standard sterile dressing DEVICE

A standard, sterile island dressing

Standard sterile dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing surgical repair of ventral or incisional hernias greater than 3 cm in largest diameter
• have one or more of the following risk factors for post-operative surgical site complications:
• Body Mass Index (BMI) greater than or equal to 30
• diagnosis of diabetes mellitus (either type I or II)
• previous history of hernia recurrence
• active smoker
• presence of colostomy or ileostomy
• age greater than 64
• chronic obstructive pulmonary disease
• chronic kidney disease
• clinically immunocompromised.

You may not qualify if:

• the abdomen is left open post-operatively, or
• if the patient has a sensitivity to silver.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Niagara Health St. Catharines Site

St. Catharines, Ontario, L2R 2A8, Canada

Location

Related Publications (33)

• 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.

  PMID: 29700567 BACKGROUND

• Nguyen MT, Berger RL, Hicks SC, Davila JA, Li LT, Kao LS, Liang MK. Comparison of outcomes of synthetic mesh vs suture repair of elective primary ventral herniorrhaphy: a systematic review and meta-analysis. JAMA Surg. 2014 May;149(5):415-21. doi: 10.1001/jamasurg.2013.5014.

  PMID: 24554114 BACKGROUND

• Lee L, Mata J, Landry T, Khwaja KA, Vassiliou MC, Fried GM, Feldman LS. A systematic review of synthetic and biologic materials for abdominal wall reinforcement in contaminated fields. Surg Endosc. 2014 Sep;28(9):2531-46. doi: 10.1007/s00464-014-3499-5. Epub 2014 Mar 12.

  PMID: 24619334 BACKGROUND

• Castro PM, Rabelato JT, Monteiro GG, del Guerra GC, Mazzurana M, Alvarez GA. Laparoscopy versus laparotomy in the repair of ventral hernias: systematic review and meta-analysis. Arq Gastroenterol. 2014 Jul-Sep;51(3):205-11. doi: 10.1590/s0004-2803201400030008.

  PMID: 25296080 BACKGROUND

• Fischer JP, Wink JD, Nelson JA, Kovach SJ 3rd. Among 1,706 cases of abdominal wall reconstruction, what factors influence the occurrence of major operative complications? Surgery. 2014 Feb;155(2):311-9. doi: 10.1016/j.surg.2013.08.014.

  PMID: 24433774 BACKGROUND

• Lovecchio F, Farmer R, Souza J, Khavanin N, Dumanian GA, Kim JY. Risk factors for 30-day readmission in patients undergoing ventral hernia repair. Surgery. 2014 Apr;155(4):702-10. doi: 10.1016/j.surg.2013.12.021. Epub 2013 Dec 25.

  PMID: 24612622 BACKGROUND

• Badia JM, Casey AL, Petrosillo N, Hudson PM, Mitchell SA, Crosby C. Impact of surgical site infection on healthcare costs and patient outcomes: a systematic review in six European countries. J Hosp Infect. 2017 May;96(1):1-15. doi: 10.1016/j.jhin.2017.03.004. Epub 2017 Mar 8.

  PMID: 28410761 BACKGROUND

• Correa NF, de Brito MJ, de Carvalho Resende MM, Duarte MF, Santos FS, Salome GM, Ferreira LM. Impact of surgical wound dehiscence on health-related quality of life and mental health. J Wound Care. 2016 Oct 2;25(10):561-570. doi: 10.12968/jowc.2016.25.10.561.

  PMID: 27681586 BACKGROUND

• Gheorghe A, Moran G, Duffy H, Roberts T, Pinkney T, Calvert M. Health Utility Values Associated with Surgical Site Infection: A Systematic Review. Value Health. 2015 Dec;18(8):1126-37. doi: 10.1016/j.jval.2015.08.004. Epub 2015 Sep 26.

  PMID: 26686800 BACKGROUND

• Guest JF, Fuller GW, Vowden P. Costs and outcomes in evaluating management of unhealed surgical wounds in the community in clinical practice in the UK: a cohort study. BMJ Open. 2018 Dec 14;8(12):e022591. doi: 10.1136/bmjopen-2018-022591.

  PMID: 30552253 BACKGROUND

• Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.

  PMID: 9188971 BACKGROUND

• Capobianco CM, Zgonis T. An overview of negative pressure wound therapy for the lower extremity. Clin Podiatr Med Surg. 2009 Oct;26(4):619-31. doi: 10.1016/j.cpm.2009.08.002.

  PMID: 19778692 BACKGROUND

• Ma Z, Li Z, Shou K, Jian C, Li P, Niu Y, Qi B, Yu A. Negative pressure wound therapy: Regulating blood flow perfusion and microvessel maturation through microvascular pericytes. Int J Mol Med. 2017 Nov;40(5):1415-1425. doi: 10.3892/ijmm.2017.3131. Epub 2017 Sep 13.

  PMID: 28901392 BACKGROUND

• 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.

  PMID: 9188970 BACKGROUND

• Orgill DP, Manders EK, Sumpio BE, Lee RC, Attinger CE, Gurtner GC, Ehrlich HP. The mechanisms of action of vacuum assisted closure: more to learn. Surgery. 2009 Jul;146(1):40-51. doi: 10.1016/j.surg.2009.02.002. Epub 2009 Apr 19. No abstract available.

  PMID: 19541009 BACKGROUND

• Scherer SS, Pietramaggiori G, Mathews JC, Prsa MJ, Huang S, Orgill DP. The mechanism of action of the vacuum-assisted closure device. Plast Reconstr Surg. 2008 Sep;122(3):786-797. doi: 10.1097/PRS.0b013e31818237ac.

  PMID: 18766042 BACKGROUND

• Moues CM, Vos MC, van den Bemd GJ, Stijnen T, Hovius SE. Bacterial load in relation to vacuum-assisted closure wound therapy: a prospective randomized trial. Wound Repair Regen. 2004 Jan-Feb;12(1):11-7. doi: 10.1111/j.1067-1927.2004.12105.x.

  PMID: 14974959 BACKGROUND

• Dohmen PM, Markou T, Ingemansson R, Rotering H, Hartman JM, van Valen R, Brunott M, Segers P. Use of incisional negative pressure wound therapy on closed median sternal incisions after cardiothoracic surgery: clinical evidence and consensus recommendations. Med Sci Monit. 2014 Oct 4;20:1814-25. doi: 10.12659/MSM.891169.

  PMID: 25280449 BACKGROUND

• 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.

  PMID: 26239514 BACKGROUND

• Conde-Green A, Chung TL, Holton LH 3rd, Hui-Chou HG, Zhu Y, Wang H, Zahiri H, Singh DP. Incisional negative-pressure wound therapy versus conventional dressings following abdominal wall reconstruction: a comparative study. Ann Plast Surg. 2013 Oct;71(4):394-7. doi: 10.1097/SAP.0b013e31824c9073.

  PMID: 22868327 BACKGROUND

• Pauli EM, Krpata DM, Novitsky YW, Rosen MJ. Negative pressure therapy for high-risk abdominal wall reconstruction incisions. Surg Infect (Larchmt). 2013 Jun;14(3):270-4. doi: 10.1089/sur.2012.059. Epub 2013 Apr 16.

  PMID: 23590852 BACKGROUND

• Swanson EW, Cheng HT, Susarla SM, Lough DM, Kumar AR. Does negative pressure wound therapy applied to closed incisions following ventral hernia repair prevent wound complications and hernia recurrence? A systematic review and meta-analysis. Plast Surg (Oakv). 2016 Summer;24(2):113-8. Epub 2016 May 27.

  PMID: 27441196 BACKGROUND

• Abesamis GM, Chopra S, Vickery K, Deva AK. A Comparative Trial of Incisional Negative-Pressure Wound Therapy in Abdominoplasty. Plast Reconstr Surg Glob Open. 2019 May 16;7(5):e2141. doi: 10.1097/GOX.0000000000002141. eCollection 2019 May.

  PMID: 31333924 BACKGROUND

• Hussamy DJ, Wortman AC, McIntire DD, Leveno KJ, Casey BM, Roberts SW. Closed Incision Negative Pressure Therapy in Morbidly Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Oct;134(4):781-789. doi: 10.1097/AOG.0000000000003465.

  PMID: 31503147 BACKGROUND

• Ren H, Li Y. Severe complications after negative pressure wound therapy in burned wounds: two case reports. Ther Clin Risk Manag. 2014 Jul 1;10:513-6. doi: 10.2147/TCRM.S66117. eCollection 2014.

  PMID: 25061310 BACKGROUND

• Li Z, Yu A. Complications of negative pressure wound therapy: a mini review. Wound Repair Regen. 2014 Jul-Aug;22(4):457-61. doi: 10.1111/wrr.12190.

  PMID: 24852446 BACKGROUND

• Webster J, Liu Z, Norman G, Dumville JC, Chiverton L, Scuffham P, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2019 Mar 26;3(3):CD009261. doi: 10.1002/14651858.CD009261.pub4.

  PMID: 30912582 BACKGROUND

• 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.

  PMID: 28951263 BACKGROUND

• Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.

  PMID: 21804414 BACKGROUND

• 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.

  PMID: 21761149 BACKGROUND

• Masden D, Goldstein J, Endara M, Xu K, Steinberg J, Attinger C. Negative pressure wound therapy for at-risk surgical closures in patients with multiple comorbidities: a prospective randomized controlled study. Ann Surg. 2012 Jun;255(6):1043-7. doi: 10.1097/SLA.0b013e3182501bae.

  PMID: 22549748 BACKGROUND

• 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.

  PMID: 23111014 BACKGROUND

• 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.

  PMID: 24851729 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher E Blewett, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Given the physical differences in the negative pressure wound therapy systems compared to standard sterile dressings, patient participants and care providers will not be able to be blinded. Ultrasound evaluators and statisticians, however, will be.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: December 14, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)