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出境医 / 临床实验 / Efficacy of NPWT in Reducing the Incidence of Wound Infection After Pancreatic Surgery

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Device: Disposable negative wound pressure device (PICO) Device: OPsite post-op visible standard sterile dressing Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of a Disposable Negative Wound Pressure Device in Reducing the Incidence of Non-organ Space Surgical Site Infection After Clean-contaminated Pancreatic Resections: a Randomized Controlled Trial
Actual Study Start Date : July 25, 2018
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 10, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Device: Disposable negative wound pressure device (PICO)
Application of a disposable negative wound pressure device for surgical site infection prevention.
Active Comparator: 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.
 Device: OPsite post-op visible standard sterile dressing
Application of a standard sterile wound dressing.
Outcome Measures
Primary Outcome Measures :
  1. Surgical Site Infection (non-organ space) [ Time Frame: 30 days from index surgery ]
    Superficial + deep surgical site infection as defined by CDC


Secondary Outcome Measures :
  1. Rate of discontinuation of negative wound pressure therapy [ Time Frame: 7 days from index surgery ]
    Discontinuation of therapy due to patient choice

  2. Incidence of seromas [ Time Frame: 30 days from index surgery ]
    As defined by CDC

  3. Incidence of hematomas [ Time Frame: 30 days from index surgery ]
    As defined by CDC

  4. Incidence of major morbidities [ Time Frame: 30 days from index surgery ]
    Incidence of pancreatic fistula, hemorrhage, delayed gastric emptying, Clavien -Dindo morbidity

  5. Stony Brook Scar Evaluation Scale Score [ Time Frame: 30 days after index surgery ]
    The Stony Brook Evaluation Scale evaluate the aesthetic result of an incision. Score ranges from 0 (worst aesthetic result) to 5 (best aesthetic result)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
Italy
Ospedale Policlinico GB Rossi
Verona, Italy, 37134
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Smith & Nephew Wound Management Inc
Investigators
Layout table for investigator information
Principal Investigator: Luca Landoni, MD AOVR Veneto
Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE July 25, 2018
Actual Primary Completion Date October 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020) 		Surgical Site Infection (non-organ space) [ Time Frame: 30 days from index surgery ]
Superficial + deep surgical site infection as defined by CDC
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018) 		Surgical Site Infection [ Time Frame: 30 days from index surgery ]
Superficial + deep surgical site infection as defined by CDC
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • Rate of discontinuation of negative wound pressure therapy [ Time Frame: 7 days from index surgery ]
    Discontinuation of therapy due to patient choice
  • Incidence of seromas [ Time Frame: 30 days from index surgery ]
    As defined by CDC
  • Incidence of hematomas [ Time Frame: 30 days from index surgery ]
    As defined by CDC
  • Incidence of major morbidities [ Time Frame: 30 days from index surgery ]
    Incidence of pancreatic fistula, hemorrhage, delayed gastric emptying, Clavien -Dindo morbidity
  • Stony Brook Scar Evaluation Scale Score [ Time Frame: 30 days after index surgery ]
    The Stony Brook Evaluation Scale evaluate the aesthetic result of an incision. Score ranges from 0 (worst aesthetic result) to 5 (best aesthetic result)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • Rate of discontinuation of negative wound pressure therapy [ Time Frame: 7 days from index surgery ]
    Discontinuation of therapy due to patient choice
  • Incidence of seromas [ Time Frame: 30 days from index surgery ]
    As defined by CDC
  • Incidence of hematomas [ Time Frame: 30 days from index surgery ]
    As defined by CDC
  • Incidence of major morbidities [ Time Frame: 30 days from index surgery ]
    Incidence of pancreatic fistula, hemorrhage, delayed gastric emptying, Clavien -Dindo morbidity
  • Stony Brook Scar Evaluation Scale Score [ Time Frame: 30 days after index surgery ]
    The Stony Brook Evaluation Scale evaluate the aesthetic result of an incision. Score ranges from 0 (worst aesthetic result) to 5 (best aesthetic result)
  • Costs [ Time Frame: 30 days after index surgery ]
    calculated on the basis of the daily cost per device multiplied by the days of hospital stay
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of NPWT in Reducing the Incidence of Wound Infection After Pancreatic Surgery
Official Title  ICMJE Efficacy of a Disposable Negative Wound Pressure Device in Reducing the Incidence of Non-organ Space Surgical Site Infection After Clean-contaminated Pancreatic Resections: a Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
1:1 randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Surgical Site Infection
Intervention  ICMJE
  • Device: Disposable negative wound pressure device (PICO)
    Application of a disposable negative wound pressure device for surgical site infection prevention.
  • Device: OPsite post-op visible standard sterile dressing
    Application of a standard sterile wound dressing.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Device: Disposable negative wound pressure device (PICO)
  • Active Comparator: 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.
    Intervention: Device: OPsite post-op visible standard sterile dressing
Publications *
  • Fiorio M, Marvaso A, Viganò F, Marchetti F. Incidence of surgical site infections in general surgery in Italy. Infection. 2006 Dec;34(6):310-4.
  • 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. Review.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Grauhan O, Navasardyan A, Hofmann M, Müller 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.
  • 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. Review. Update in: Cochrane Database Syst Rev. 2014;(10):CD009261.
  • Malmsjö M, Huddleston E, Martin R. Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty. 2014 Apr 2;14:e15. eCollection 2014.
  • 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, Fernández-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.
  • 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.
  • 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.
  • Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Büchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 Jul;142(1):20-5. Review.
  • Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Büchler 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.
  • 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. Review.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2018) 		100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 10, 2019
Actual Primary Completion Date October 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03700086
Other Study ID Numbers  ICMJE PICO (1215CESC)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Azienda Ospedaliera Universitaria Integrata Verona
Study Sponsor  ICMJE Azienda Ospedaliera Universitaria Integrata Verona
Collaborators  ICMJE Smith & Nephew Wound Management Inc
Investigators  ICMJE
Principal Investigator: Luca Landoni, MD AOVR Veneto
PRS Account Azienda Ospedaliera Universitaria Integrata Verona
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP