Efficacy of NPWT in Reducing the Incidence of Wound Infection After Pancreatic Surgery

NCT03700086 | Completed

• 1 other identifier: PICO (1215CESC)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A disposable negative wound pressure device will be compared to standard sterile wound dressing in reducing the rate of wound infection after clean-contaminated surgical procedures on biliary tract and pancreas in patients at high risk for wound infection.

Conditions

Surgical Site Infection

Keywords

negative pressure wound therapy; wound infection; pancreaticoduodenectomy; total pancreatectomy; surgical palliation of pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection (non-organ space)

  Superficial + deep surgical site infection as defined by CDC

  30 days from index surgery

Secondary Outcomes (5)

• Rate of discontinuation of negative wound pressure therapy

  7 days from index surgery

• Incidence of seromas

  30 days from index surgery

• Incidence of hematomas

  30 days from index surgery

• Incidence of major morbidities

  30 days from index surgery

• Stony Brook Scar Evaluation Scale Score

  30 days after index surgery

Study Arms (2)

Negative wound pressure device (PICO)

EXPERIMENTAL

The disposable negative wound pressure device (PICO) will be used to cover the midline incision. The dressing is changed on POD3 and removed on POD7. Data are collected on POD3, POD7 and POD30.

Device: Disposable negative wound pressure device (PICO)

Standard sterile dressing

ACTIVE COMPARATOR

The OPsite post-op visible standard sterile dressing will be used to cover the midline incision. Dressing is changed q48h. Data are collected on POD3, POD7 and POD30.

Device: OPsite post-op visible standard sterile dressing

Interventions

Disposable negative wound pressure device (PICO) DEVICE

Application of a disposable negative wound pressure device for surgical site infection prevention.

Negative wound pressure device (PICO)

OPsite post-op visible standard sterile dressing DEVICE

Application of a standard sterile wound dressing.

Standard sterile dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Informed consent
• HPB clean-contaminated procedures (PD, TP and GEA/HJ)
• Median laparotomy
• Compliance with a follow-up protocol
• High risk for SSI (at least one of the following):
• Body Mass Index \> 30kg/m2
• Diabetes mellitus type I or II
• Use of steroids
• Neoadjuvant therapy
• ASA ≥ 3
• Charlson Comorbidity Index 1
• Time of surgery \> 360'
• Estimated blood loss \> 1L

You may not qualify if:

• Previous open surgery of the abdomen
• Unable to give informed consent

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• Smith & Nephew Wound Management Inc: collaborator

Study Sites (1)

Ospedale Policlinico GB Rossi

Verona, 37134, Italy

Location

Related Publications (21)

• Fiorio M, Marvaso A, Vigano F, Marchetti F. Incidence of surgical site infections in general surgery in Italy. Infection. 2006 Dec;34(6):310-4. doi: 10.1007/s15010-006-6632-0.

  PMID: 17180584 RESULT

• Allegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, Pittet D. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011 Jan 15;377(9761):228-41. doi: 10.1016/S0140-6736(10)61458-4. Epub 2010 Dec 9.

  PMID: 21146207 RESULT

• 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.

  PMID: 10219875 RESULT

• Ceppa EP, Pitt HA, House MG, Kilbane EM, Nakeeb A, Schmidt CM, Zyromski NJ, Lillemoe KD. Reducing surgical site infections in hepatopancreatobiliary surgery. HPB (Oxford). 2013 May;15(5):384-91. doi: 10.1111/j.1477-2574.2012.00604.x. Epub 2012 Nov 5.

  PMID: 23557410 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Vargo D. Negative pressure wound therapy in the prevention of wound infection in high risk abdominal wound closures. Am J Surg. 2012 Dec;204(6):1021-3; discussion 1023-4. doi: 10.1016/j.amjsurg.2012.10.004.

  PMID: 23231938 RESULT

• Blackham AU, Farrah JP, McCoy TP, Schmidt BS, Shen P. Prevention of surgical site infections in high-risk patients with laparotomy incisions using negative-pressure therapy. Am J Surg. 2013 Jun;205(6):647-54. doi: 10.1016/j.amjsurg.2012.06.007. Epub 2013 Jan 30.

  PMID: 23375758 RESULT

• Bonds AM, Novick TK, Dietert JB, Araghizadeh FY, Olson CH. Incisional negative pressure wound therapy significantly reduces surgical site infection in open colorectal surgery. Dis Colon Rectum. 2013 Dec;56(12):1403-8. doi: 10.1097/DCR.0b013e3182a39959.

  PMID: 24201395 RESULT

• 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 RESULT

• Webster J, Scuffham P, Sherriff KL, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD009261. doi: 10.1002/14651858.CD009261.pub2.

  PMID: 22513974 RESULT

• Malmsjo M, Huddleston E, Martin R. Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty. 2014 Apr 2;14:e15. eCollection 2014.

  PMID: 24741386 RESULT

• Fong ZV, McMillan MT, Marchegiani G, Sahora K, Malleo G, De Pastena M, Loehrer AP, Lee GC, Ferrone CR, Chang DC, Hutter MM, Drebin JA, Bassi C, Lillemoe KD, Vollmer CM, Fernandez-Del Castillo C. Discordance Between Perioperative Antibiotic Prophylaxis and Wound Infection Cultures in Patients Undergoing Pancreaticoduodenectomy. JAMA Surg. 2016 May 1;151(5):432-9. doi: 10.1001/jamasurg.2015.4510.

  PMID: 26720272 RESULT

• Payne C, Edwards D. Application of the Single Use Negative Pressure Wound Therapy Device (PICO) on a Heterogeneous Group of Surgical and Traumatic Wounds. Eplasty. 2014 Apr 28;14:e20. eCollection 2014.

  PMID: 24917894 RESULT

• Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Am J Infect Control. 1992 Oct;20(5):271-4. doi: 10.1016/s0196-6553(05)80201-9. No abstract available.

  PMID: 1332552 RESULT

• Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Buchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 Jul;142(1):20-5. doi: 10.1016/j.surg.2007.02.001.

  PMID: 17629996 RESULT

• Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.

  PMID: 17981197 RESULT

• Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.

  PMID: 16003309 RESULT

• Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.

  PMID: 18090752 RESULT

• Pellino G, Sciaudone G, Candilio G, Campitiello F, Selvaggi F, Canonico S. Effects of a new pocket device for negative pressure wound therapy on surgical wounds of patients affected with Crohn's disease: a pilot trial. Surg Innov. 2014 Apr;21(2):204-12. doi: 10.1177/1553350613496906. Epub 2013 Jul 24.

  PMID: 23883481 RESULT

MeSH Terms

Conditions

Surgical Wound Infection; Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luca Landoni, MD

  AOVR Veneto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomized controlled trial

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: October 9, 2018
• Study Start: July 25, 2018
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: May 8, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)