Postoperative Surgical Site InfectionsNEPTUNENCT02007018
Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
A study testing Negative Pressure Wound Therapy in people with Postoperative Surgical Site Infections, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Surgical Site Infections
- What is being tested?
- Negative Pressure Wound Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2015to 1 Sep 2017
- 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 years
- Planned elective colorectal resection (those that occur as a scheduled operation in the surgeons' planned operative list)
Who cannot join
- Palliative colorectal resection where predicted remaining lifespan is likely less than 30 days
- Abdominoperineal resection or pelvic exenteration
- Known allergy/sensitivity to adhesive
- Cases in which there is a suspicion of bowel perforation
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
London Health Sciences Centre - University Campus
London, Ontario, N6A 5A5
London Health Sciences Centre - Victoria Campus
London, Ontario, N6A 5W9
About this study
The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return visits related to SSI.
Read the detailed description
The proposed trial will be pragmatic in nature whereby the investigators are trying to simulate usual circumstances to inform their everyday clinical decisions on the utility of negative pressure wound therapy (NPWT). A prospective randomized open label blind endpoint (PROBE) trial design was chosen. All patients scheduled to undergo elective colorectal resections (CRR) at London Health Sciences Centre (LHSC) will be identified at the time of a pre-operative clinic visit with one of the 13 surgeons performing CRR at their institution. Included patients will be randomized to receive either usual care or usual care plus NPWT. All patients will be followed for 30 post-operative days to identify the development of an SSI and other secondary outcomes. Given the nature of the intervention, the surgeon and patients cannot be blinded to the intervention. Outcome assessors and statisticians will be blinded to the patient's allocated group.
- Conditions
- Postoperative Surgical Site Infections
- Being tested
- Negative Pressure Wound Therapy, Usual Care of Surgical Wound
- Keywords
- Surgical Site Infections, Colorectal Resection, Negative Pressure Wound Therapy
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Also called Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI)
Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI), San Antonio, TX) is an incisional vacuum assisted closure (PIMS) device intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy The PIMS applies continuous pressure to the closed surgical site at 125 mm Hg and is attached to a 45 mL canister for collection of exudate.
Usual Care of Surgical WoundOther
Patients will receive pre-operative antibiotics consisting of 1g cefazolin (or in the case of an allergy, an alternative e.g. ciprofloxacin/vancomycin) and 500 mg metronidazole given intravenously within the 30 minute prior to beginning the operative procedure. In cases extending > 4 hours, a second dose of each of the antibiotics will be administered. Hair at the operative site will be removed, if required, immediately prior to the skin incision using electric clippers. The abdomen will be prepped using 2% Chlorhexidiene solution (or 10% povidone if allergic). After closure of the skin, the surgical wound will be covered with a sterile adhesive dressing (Tegaderm), which will remain in place until the morning of post-operative day (POD)#2, unless saturated, in which case it is standard practice to change the dressing if the physician is in agreement. On POD#2, the surgical team will remove the initial dressing and daily dressing changes with standard gauze will be initiated.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | This group will receive the usual care of surgical wound AND Negative Pressure Wound Therapy (NPWT). The Prevena™ Incision Management System (PIMS) is placed in a sterile fashion over the closed surgical site prior to leaving the operating room. The PIMS is to remain in place until the completion of therapy at five days. Receives: Device: Negative Pressure Wound Therapy; Other: Usual Care of Surgical Wound |
| Usual Care of Surgical Wound | Active comparator | This group will receive the usual care of a surgical wound. Receives: Other: Usual Care of Surgical Wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Surgical Site Infection (SSI)
Postoperative surgical site infection (SSI), as defined by the following CDC (Centre for Disease Control) criteria:
Infection occurring within the first 30 post-operative days with at least one of the following:
- Purulent drainage from the incision
- Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision
- At least one of the following signs/symptoms of infection
- Pain or tenderness
- Localized swelling
- Redness
- Heat AND incision is deliberately opened by a surgeon (unless incision is culture negative)
- Diagnosis of SSI by the surgeon or attending physician
Measured: 30 days following operation
Secondary outcomes (4)
Need for Home Nursing Care (Home Care) related to Surgical Site Infection (SSI)
The need for home care will be determined by the surgical team after the identification of an SSI, and will be recorded by the study team. The duration of home care requirements will be determined at the time of post-operative clinic visits, as the home care process requires ongoing written communication with the surgeon for the duration of therapy, and this communication is concurrently occurring at the time of clinic visits.
Measured: Up to 60 days post-operatively to encompass the treatment period required for the SSI.
Length of Stay in Hospital
Time from surgery to discharge from hospital.
Measured: Up to 60 days post-operatively to encompass the prolonged stay in hospital of some patients
Cost of Management of Surgical Site Infection (SSI)
The cost of each SSI will be determined using the hospital case-costing dataset for inpatient care, clinic visits, and emergency department visits, and the standardized time and materials costs available from the Community Care Access Centre for home care.
Measured: Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
Number of Return Visits Related to Surgical Site Infection
A return visit related to SSI will include any visit to the emergency department, outpatient surgical clinic, or requirement for admission to hospital that is deemed by the primary surgeon or study team to be due to a) signs or symptoms of SSI requiring assessment; b) development of an SSI requiring management; or c) ongoing care of a known SSI
Measured: Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study start1 Jan 2015
- Primary completion6 Mar 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Surgical Site InfectionsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Ott, MD, MSc, FRCSC, FACS, FASCRS, Principal investigator, Division of General Surgery, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007018
- Sponsor's protocol ID
- NEPTUNE
- Acronym
- NEPTUNE
- Status last verified
- Oct 2018
- First submitted
- 5 Dec 2013
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Murphy PB, Knowles S, Chadi SA, Vogt K, Brackstone M, Koughnett JAV, Ott MC. Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE): A Randomized Controlled Trial. Ann Surg. 2019 Jul;270(1):38-42. doi: 10.1097/SLA.0000000000003111.
PubMed 30499799Chadi SA, Vogt KN, Knowles S, Murphy PB, Van Koughnett JA, Brackstone M, Ott MC. Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial. Trials. 2015 Jul 30;16:322. doi: 10.1186/s13063-015-0817-8.
PubMed 26223227
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
- ClinicalTrials.gov ID
- NCT02007018
- Acronym / sponsor ID
- NEPTUNE / NEPTUNE
- Conditions
- Postoperative Surgical Site Infections
- Keywords
- Surgical Site Infections, Colorectal Resection, Negative Pressure Wound Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 10 Dec 2013 (estimated)
- 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.
The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return visits related to SSI.
Detailed description
The proposed trial will be pragmatic in nature whereby the investigators are trying to simulate usual circumstances to inform their everyday clinical decisions on the utility of negative pressure wound therapy (NPWT). A prospective randomized open label blind endpoint (PROBE) trial design was chosen. All patients scheduled to undergo elective colorectal resections (CRR) at London Health Sciences Centre (LHSC) will be identified at the time of a pre-operative clinic visit with one of the 13 surgeons performing CRR at their institution. Included patients will be randomized to receive either usual care or usual care plus NPWT. All patients will be followed for 30 post-operative days to identify the development of an SSI and other secondary outcomes. Given the nature of the intervention, the surgeon and patients cannot be blinded to the intervention. Outcome assessors and statisticians will be blinded to the patient's allocated group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound Therapy, Other: Usual Care of Surgical WoundThis group will receive the usual care of surgical wound AND Negative Pressure Wound Therapy (NPWT). The Prevena™ Incision Management System (PIMS) is placed in a sterile fashion over the closed surgical site prior to leaving the operating room. The PIMS is to remain in place until the completion of therapy at five days. |
| Usual Care of Surgical Wound | Active comparator | Other: Usual Care of Surgical WoundThis group will receive the usual care of a surgical wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Planned elective colorectal resection (those that occur as a scheduled operation in the surgeons' planned operative list)
Key exclusion criteria (5 listed)
- Palliative colorectal resection where predicted remaining lifespan is likely less than 30 days
- Abdominoperineal resection or pelvic exenteration
- Known allergy/sensitivity to adhesive
- Cases in which there is a suspicion of bowel perforation
- Pregnancy
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 |
|---|---|---|
| Negative Pressure Wound TherapyAlso: Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI)Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI), San Antonio, TX) is an incisional vacuum assisted closure (PIMS) device intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy The PIMS applies continuous pressure to the closed surgical site at 125 mm Hg and is attached to a 45 mL canister for collection of exudate. | Device | Negative Pressure Wound Therapy |
| Usual Care of Surgical WoundPatients will receive pre-operative antibiotics consisting of 1g cefazolin (or in the case of an allergy, an alternative e.g. ciprofloxacin/vancomycin) and 500 mg metronidazole given intravenously within the 30 minute prior to beginning the operative procedure. In cases extending > 4 hours, a second dose of each of the antibiotics will be administered. Hair at the operative site will be removed, if required, immediately prior to the skin incision using electric clippers. The abdomen will be prepped using 2% Chlorhexidiene solution (or 10% povidone if allergic). After closure of the skin, the surgical wound will be covered with a sterile adhesive dressing (Tegaderm), which will remain in place until the morning of post-operative day (POD)#2, unless saturated, in which case it is standard practice to change the dressing if the physician is in agreement. On POD#2, the surgical team will remove the initial dressing and daily dressing changes with standard gauze will be initiated. | Other | Negative Pressure Wound Therapy, Usual Care of Surgical Wound |
Primary outcome
Postoperative Surgical Site Infection (SSI)
Time frame: 30 days following operation
Postoperative surgical site infection (SSI), as defined by the following CDC (Centre for Disease Control) criteria: Infection occurring within the first 30 post-operative days with at least one of the following: 1. Purulent drainage from the incision 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision 3. At least one of the following signs/symptoms of infection * Pain or tenderness * Localized swelling * Redness * Heat AND incision is deliberately opened by a surgeon (unless incision is culture negative) 4. Diagnosis of SSI by the surgeon or attending physician
4 secondary outcomes
Need for Home Nursing Care (Home Care) related to Surgical Site Infection (SSI)
Time frame: Up to 60 days post-operatively to encompass the treatment period required for the SSI.
Length of Stay in Hospital
Time frame: Up to 60 days post-operatively to encompass the prolonged stay in hospital of some patients
Cost of Management of Surgical Site Infection (SSI)
Time frame: Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
Number of Return Visits Related to Surgical Site Infection
Time frame: Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
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 19 Oct 2018.
- Derived from this study: PubMed 30499799Murphy PB, Knowles S, Chadi SA, Vogt K, Brackstone M, Koughnett JAV, Ott MC. Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE): A Randomized Controlled Trial. Ann Surg. 2019 Jul;270(1):38-42. doi: 10.1097/SLA.0000000000003111.
- Derived from this study: PubMed 26223227Chadi SA, Vogt KN, Knowles S, Murphy PB, Van Koughnett JA, Brackstone M, Ott MC. Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial. Trials. 2015 Jul 30;16:322. doi: 10.1186/s13063-015-0817-8.
- 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.
Michael Ott, MD, MSc, FRCSC, FACS, FASCRS principal investigator
Division of General Surgery, Western University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy in people with Postoperative Surgical Site Infections, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
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 2 inclusion and 5 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 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Postoperative Surgical Site Infection (SSI) (time frame: 30 days following operation). 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 NCT02007018, which also lists 2 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 19 Oct 2018.