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

NCT ID: NCT03700086

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-25
• Study Completion Date: 2019-10-10

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.

Detailed Description

The use of specific protocols for antisepsis, sterilization and infections' prophylaxis is widely diffused, but, however, surgical site infection rate is still high. Wound infection is often considered as a minor morbidity if compared with other complications, but it is able to considerably increase the length of hospital stay, health care and assistance related costs affecting patients' quality of life. The Center for Disease Control and Prevention (CDC) has published specific guidelines for surgical site infection (SSI) prevention that includes hairs removal, intravenous antibiotics on the basis of the type of procedure planned for that patient, skin antisepsis, surgical team antisepsis, sterility, blood glucose levels control, body temperature control and optimal perfusion of all tissues. At the end of the surgical procedure, surgical incision is covered with a sterile dressing that usually is changed after 24/48 hours. Clean-contaminated procedures like pancreaticoduodenectomy (PD), total pancreatectomy (TP) and palliative procedures like gastric by-pass and hepaticojejunostomy GEA/HJ) are considered at high complexity with a high incidence of SSI, especially dealing with patients at high surgical risk. Since from the introduction of negative wound pressure therapy in 1997, these devices have been used only for the treatment of acute and chronic wounds with loss of tissue, but recently have also been proposed in the setting of SSI prevention. Negative wound pressure systems have higher costs, the use in the outpatients setting may be complex consequently the use in the setting of SSI prevention could not result cost-effective.

The rationale for the use of negative pressure therapy in the prevention of SSI relies in the complete clearance of dead-space under the incision, fluids and blood removal with consequent reduction of fluids infections, edema reduction, blood flow improvement and tissue oxygenation. Similar results can be obtained through a less expensive, disposable, canisterless, negative pressure wound therapy device (Pico®, Smith&Nephew). This system is cheaper, is portable, and can produce a continue vacuum with a nominal pressure of -80mmHg being able to achieve a rapid discharge at home with less frequent medications, improved comfort and aesthetic result.

The following study is designed to assess the effect of a disposable, canisterless, negative pressure wound therapy device in the reduction of SSI in high risk patients if compared with a sterile standard dressing after major pancreatic procedures.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Negative wound pressure device (PICO)

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.

Group Type: EXPERIMENTAL

Disposable negative wound pressure device (PICO)

Intervention Type: DEVICE

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

Standard sterile dressing

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.

Group Type: ACTIVE_COMPARATOR

OPsite post-op visible standard sterile dressing

Intervention Type: DEVICE

Application of a standard sterile wound dressing.

Interventions

Disposable negative wound pressure device (PICO)

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

Intervention Type: DEVICE

OPsite post-op visible standard sterile dressing

Application of a standard sterile wound dressing.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Wound Management Inc

INDUSTRY

Sponsor Role: collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Landoni, MD

Role: PRINCIPAL_INVESTIGATOR

AOVR Veneto

Locations

Ospedale Policlinico GB Rossi

Verona, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 17180584 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21146207 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10219875 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23557410 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9188971 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9188970 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22549748 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23231938 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23375758 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24201395 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23111014 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22513974 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24741386 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26720272 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24917894 (View on PubMed)

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.

Reference Type: RESULT

PMID: 1332552 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17629996 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17981197 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16003309 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18090752 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23883481 (View on PubMed)

Other Identifiers

PICO (1215CESC)

Identifier Type: -

Identifier Source: org_study_id