Surgical Site InfectionNCT03700086
Efficacy of NPWT in Reducing the Incidence of Wound Infection After Pancreatic Surgery
A study testing Disposable negative wound pressure device (PICO) and OPsite post-op visible standard sterile dressing in people with Surgical Site Infection, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Disposable negative wound pressure device (PICO) and OPsite post-op visible standard sterile dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jul 2018to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
Show all 14Show fewer
- 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
Who cannot join
- Previous open surgery of the abdomen
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Disposable negative wound pressure device (PICO), OPsite post-op visible standard sterile dressing
- Keywords
- negative pressure wound therapy, wound infection, pancreaticoduodenectomy, total pancreatectomy, surgical palliation of pancreatic cancer
- Medical subject headings
- Surgical Wound Infection, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable negative wound pressure device (PICO)Device
Application of a disposable negative wound pressure device for surgical site infection prevention.
OPsite post-op visible standard sterile dressingDevice
Application of a standard sterile wound dressing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: OPsite post-op visible standard sterile dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (non-organ space)
Superficial + deep surgical site infection as defined by CDC
Measured: 30 days from index surgery
Secondary outcomes (5)
Rate of discontinuation of negative wound pressure therapy
Discontinuation of therapy due to patient choice
Measured: 7 days from index surgery
Incidence of seromas
As defined by CDC
Measured: 30 days from index surgery
Incidence of hematomas
As defined by CDC
Measured: 30 days from index surgery
Incidence of major morbidities
Incidence of pancreatic fistula, hemorrhage, delayed gastric emptying, Clavien -Dindo morbidity
Measured: 30 days from index surgery
Stony Brook Scar Evaluation Scale Score
The Stony Brook Evaluation Scale evaluate the aesthetic result of an incision. Score ranges from 0 (worst aesthetic result) to 5 (best aesthetic result)
Measured: 30 days after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start25 Jul 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew Wound Management Inc
- Responsible party
- Sponsor
- Investigators
- Luca Landoni, MD, Principal investigator, AOVR Veneto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700086
- Sponsor's protocol ID
- PICO (1215CESC)
- Status last verified
- Mar 2020
- First submitted
- 15 May 2018
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17180584Allegranzi 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.
PubMed 21146207Mangram 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.
PubMed 10219875Ceppa 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.
PubMed 23557410Argenta 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.
PubMed 9188971Morykwas 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.
PubMed 9188970Masden 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.
PubMed 22549748Vargo 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.
PubMed 23231938Blackham 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.
PubMed 23375758Bonds 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.
PubMed 24201395Grauhan 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.
PubMed 23111014Webster 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.
PubMed 22513974Malmsjo M, Huddleston E, Martin R. Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty. 2014 Apr 2;14:e15. eCollection 2014.
PubMed 24741386Fong 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.
PubMed 26720272Payne 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.
PubMed 24917894
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03700086
- Acronym / sponsor ID
- PICO (1215CESC)
- Conditions
- Surgical Site Infection
- Keywords
- negative pressure wound therapy, wound infection, pancreaticoduodenectomy, total pancreatectomy, surgical palliation of pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- Smith & Nephew Wound Management Inc
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Negative wound pressure device (PICO) | Experimental | Device: Disposable 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. |
| Standard sterile dressing | Active comparator | Device: OPsite post-op visible standard sterile dressingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age > 18
- Informed consent
- HPB clean-contaminated procedures (PD, TP and GEA/HJ)
- Median laparotomy
- Compliance with a follow-up protocol
Key exclusion criteria (2 listed)
- Previous open surgery of the abdomen
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disposable negative wound pressure device (PICO)Application of a disposable negative wound pressure device for surgical site infection prevention. | Device | Negative wound pressure device (PICO) |
| OPsite post-op visible standard sterile dressingApplication of a standard sterile wound dressing. | Device | Standard sterile dressing |
Primary outcome
Surgical Site Infection (non-organ space)
Time frame: 30 days from index surgery
Superficial + deep surgical site infection as defined by CDC
5 secondary outcomes
Rate of discontinuation of negative wound pressure therapy
Time frame: 7 days from index surgery
Incidence of seromas
Time frame: 30 days from index surgery
Incidence of hematomas
Time frame: 30 days from index surgery
Incidence of major morbidities
Time frame: 30 days from index surgery
Stony Brook Scar Evaluation Scale Score
Time frame: 30 days after index surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Results publication: PubMed 17180584Fiorio 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.
- Results publication: PubMed 21146207Allegranzi 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.
- Results publication: PubMed 10219875Mangram 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.
- Results publication: PubMed 23557410Ceppa 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.
- Results publication: PubMed 9188971Argenta 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.
- Results publication: PubMed 9188970Morykwas 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.
- Results publication: PubMed 22549748Masden 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.
- Results publication: PubMed 23231938Vargo 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.
- Results publication: PubMed 23375758Blackham 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.
- Results publication: PubMed 24201395Bonds 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.
- Results publication: PubMed 23111014Grauhan 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.
- Results publication: PubMed 22513974Webster 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Landoni, MD principal investigator
AOVR Veneto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable negative wound pressure device (PICO) and OPsite post-op visible standard sterile dressing in people with Surgical Site Infection, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (non-organ space) (time frame: 30 days from index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700086, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.