Surgical Site InfectionVACCRRNCT02967627
VAC Dressings for Colorectal Resections
A study testing Incisional Negative Pressure Wound Therapy (iNPWT) and Sterile Gauze Dressing in people with Surgical Site Infection and Wound Complication, run by University of British Columbia.
Trial summary
Surgical Site Infections (SSIs) and wound complications are common occurrences following colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has developing evidence for improving wound complication rates in certain populations. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Wound Complication, Wound Dehiscence
- What is being tested?
- Incisional Negative Pressure Wound Therapy (iNPWT) and Sterile Gauze Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Oct 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective colorectal resection for benign or malignant disease
- surgery involves an anastomosis
- open or minimally invasive technique
- midline laparotomy used for specimen extraction
Who cannot join
- under 19
- allergy/sensitivity to adhesives
- immunocompromised
- pregnant
- emergency surgery
- elective surgery
- additional procedures performed at time of surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Incisional Negative Pressure Wound Therapy Following Colorectal Resection: a Single Site, Prospective, Randomized Control Trial
Surgical Site Infections (SSIs) and wound complications are common occurrences following colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has developing evidence for improving wound complication rates in certain populations. However, there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We propose a study in which patients are randomized into one of two treatment arms: 1) incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30 days for diagnosis of infection or wound complication. We will compare primary outcomes in each group using Chi-Squared statistical testing in order to report a Absolute Risk Reduction and Number Needed to Treat
Read the detailed description
Purpose: To evaluate if incisional Negative Pressure Wound Therapy (iNPWT) confers a lower rate of Surgical Site Infection (SSI) or wound complication compared to standard treatment of elective colorectal resection laparotomies.
Justification: Colorectal resection with bowel anastomosis is a clean-contaminated procedure known to have increased rates wound complication. Techniques like the use of incisional wound barriers, antimicrobial eluding dressings or iodine washout have been assessed in an attempt to reduce occurrence. However, evidence for their efficacy is not compelling for surgeons to universally adapt. Meanwhile, negative pressure wound therapy has demonstrated impressive efficacy in the management of complex and non-healing wounds. And recently, NPWT has become an area of interest in managing, not only open wounds, but closed wounds as well. The benefit of this therapy is yet to be clearly defined in the elective colorectal resection patient population, however.
Null hypothesis: There is no difference in SSI or wound complication rate in standard and iNPWT groups.
Design: Single-institution, prospective, randomized, open-label, superiority trial
Statistical Analysis: Assuming a complication rate of 20-30% and a relative risk reduction of 50%, we will recruit 400 patients (200 in each group) to achieve a power of 80% and type 1 error of 0.05. Primary endpoints will be: Wound Complication - defined as presence of seroma, hematoma, dehiscence, SSI - and SSI reported independently. Secondary endpoints will include: Length of Stay, ER visits related to SSI, Complications (according to Clavien-Dindo classification), need for and duration of home care related to wound care, and wound VAC specific complications (local reaction to adhesive dressing, blisters, failure of vacuum, need for early removal). Primary endpoints will be assessed according to intention-to-treat principle using Pearson's chi-squared test. In the event that baseline characteristics are significantly different, a secondary analysis using multivariable logistic regression will adjust for the effect of the difference. A p value of < 0.05 will be used to determine significance. Results will be presented as an absolute risk reduction as well as number needed to treat to prevent one wound complication. Secondary outcomes will be compared using a Mann-Whitney U-test for non-normally distributed continuous variables and chi-squared for categorical data.
- Conditions
- Surgical Site Infection, Wound Complication, Wound Dehiscence, Seroma, Hematoma
- Being tested
- Incisional Negative Pressure Wound Therapy (iNPWT), Sterile Gauze Dressing
- Medical subject headings
- Surgical Wound Infection, Seroma, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional Negative Pressure Wound Therapy (iNPWT)Device
Also called Surgical Incision Management System (SIMS), Closed Incisional Negative Pressure Wound Therapy (ciNPWT), V.A.C dressing
Incisional Negative Pressure Wound Therapy devices are lightweight, self contained, portable battery powered (or line powered), suction pumps for medical procedures where secretions and other body fluids and infectious materials must be removed through the application of continuous or intermittent negative pressure. The pumps are operated through computer software, having help and alarm features. The device is indicted for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The pumps may be used at patient's bedside. These are suitable for use in either hospitals or long term care facilities and nursing homes. These devices will be applied to closed laparotomy incisions with the aim to provide three days of continuous negative pressure of - 100mmHg.
Sterile Gauze DressingDevice
Also called Self-adhesive Absorbent Dressing
In most cases, self-adhesive, absorbent dressings will be used for standard wound therapy. However, surgical teams may decide on alternative forms of sterile gauze dressings, as long as the wound site is kept clean and dry. Dressings should be taken down on the second post-operative day.
| Study group | Role | What they receive |
|---|---|---|
| Incisional Negative Pressure Wound Therapy (iNPWT) | Experimental | Patients in the iNPWT group will have their incision covered by a single layer of Mepitel wound contact layer followed by application of a KCI V.A.C Simplace ™ Dressing composed of a strip of black foam covering the entire length of the incision followed by coverage of the incision, Mepitel, and foam with an occlusive Tegederm ™ dressing to establish an airtight seal. Negative pressure will then be applied using a SensaT.R.A.C. Pad ™ to a setting of 100 mmHg continuous suction. Dressings shall remain in place and will be removed by the surgical team on the morning of the third post-operative day and left open to air thereafter. Any loss of seal of the dressing shall be reinforced using occlusive dressings. Receives: Device: Incisional Negative Pressure Wound Therapy (iNPWT) |
| Standard Therapy | Active comparator | Patients in the conventional dressings group will receive a standard Mepore ™ dressing applied to cover the entire incision. This will be left in place and and removed by the surgical team on the morning of the second postoperative day and will be left open to air thereafter. Dressings may be either reinforced or changed at the discretion of the surgical team due to drainage or saturation during the first two postoperative days. Receives: Device: Sterile Gauze Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial Surgical Site Infection (SSI)
Infection occurring within the first thirty days after surgery with at least one of the following: 1) purulent drainage from the superficial incision; 2) organisms obtained from an aseptically obtained culture of tissue or fluid from the superficial incision; 3) at least one of the local signs of infection; 4) superficial incision deliberately opened by the surgeon (unless the culture is negative)
Measured: 30 days post op
Wound Complication
At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption
Measured: 30 days post op
Secondary outcomes (5)
Length of stay
Number of days spent in hospital post op
Measured: approximately 5-10 days on average
Wound-related visits post surgery
Number of wound-related visits to primary care physician, nurse practitioner, or emergency for concerns related to laparotomy incision.
Measured: 30 days post op
Need for and duration of home care
Did the patient require home care nursing for wound care? If so, how many visits?
Measured: 30 days post op
Blistering/reaction to wound dressings
Did the patient develop skin blisters or hypersensitivity reaction secondary to their wound dressings?
Measured: 3 days post op
Post Op Complications
Did the patient develop any major complications - as according to Clavien-Dindo classification?
Measured: 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neely O.M. Panton, MD, FRCSC, Principal investigator, UBC Division of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967627
- Sponsor's protocol ID
- H16-02565
- Acronym
- VACCRR
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: To be decided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Negative Pressure Wound Therapy Following Colorectal Resection: a Single Site, Prospective, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02967627
- Acronym / sponsor ID
- VACCRR / H16-02565
- Conditions
- Surgical Site Infection, Wound Complication, Wound Dehiscence, Seroma, Hematoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 Nov 2016 (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.
Surgical Site Infections (SSIs) and wound complications are common occurrences following colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has developing evidence for improving wound complication rates in certain populations. However, there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We propose a study in which patients are randomized into one of two treatment arms: 1) incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30 days for diagnosis of infection or wound complication. We will compare primary outcomes in each group using Chi-Squared statistical testing in order to report a Absolute Risk Reduction and Number Needed to Treat
Detailed description
Purpose: To evaluate if incisional Negative Pressure Wound Therapy (iNPWT) confers a lower rate of Surgical Site Infection (SSI) or wound complication compared to standard treatment of elective colorectal resection laparotomies.
Justification: Colorectal resection with bowel anastomosis is a clean-contaminated procedure known to have increased rates wound complication. Techniques like the use of incisional wound barriers, antimicrobial eluding dressings or iodine washout have been assessed in an attempt to reduce occurrence. However, evidence for their efficacy is not compelling for surgeons to universally adapt. Meanwhile, negative pressure wound therapy has demonstrated impressive efficacy in the management of complex and non-healing wounds. And recently, NPWT has become an area of interest in managing, not only open wounds, but closed wounds as well. The benefit of this therapy is yet to be clearly defined in the elective colorectal resection patient population, however.
Null hypothesis: There is no difference in SSI or wound complication rate in standard and iNPWT groups.
Design: Single-institution, prospective, randomized, open-label, superiority trial
Statistical Analysis: Assuming a complication rate of 20-30% and a relative risk reduction of 50%, we will recruit 400 patients (200 in each group) to achieve a power of 80% and type 1 error of 0.05. Primary endpoints will be: Wound Complication - defined as presence of seroma, hematoma, dehiscence, SSI - and SSI reported independently. Secondary endpoints will include: Length of Stay, ER visits related to SSI, Complications (according to Clavien-Dindo classification), need for and duration of home care related to wound care, and wound VAC specific complications (local reaction to adhesive dressing, blisters, failure of vacuum, need for early removal). Primary endpoints will be assessed according to intention-to-treat principle using Pearson's chi-squared test. In the event that baseline characteristics are significantly different, a secondary analysis using multivariable logistic regression will adjust for the effect of the difference. A p value of < 0.05 will be used to determine significance. Results will be presented as an absolute risk reduction as well as number needed to treat to prevent one wound complication. Secondary outcomes will be compared using a Mann-Whitney U-test for non-normally distributed continuous variables and chi-squared for categorical data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incisional Negative Pressure Wound Therapy (iNPWT) | Experimental | Device: Incisional Negative Pressure Wound Therapy (iNPWT)Patients in the iNPWT group will have their incision covered by a single layer of Mepitel wound contact layer followed by application of a KCI V.A.C Simplace ™ Dressing composed of a strip of black foam covering the entire length of the incision followed by coverage of the incision, Mepitel, and foam with an occlusive Tegederm ™ dressing to establish an airtight seal. Negative pressure will then be applied using a SensaT.R.A.C. Pad ™ to a setting of 100 mmHg continuous suction. Dressings shall remain in place and will be removed by the surgical team on the morning of the third post-operative day and left open to air thereafter. Any loss of seal of the dressing shall be reinforced using occlusive dressings. |
| Standard Therapy | Active comparator | Device: Sterile Gauze DressingPatients in the conventional dressings group will receive a standard Mepore ™ dressing applied to cover the entire incision. This will be left in place and and removed by the surgical team on the morning of the second postoperative day and will be left open to air thereafter. Dressings may be either reinforced or changed at the discretion of the surgical team due to drainage or saturation during the first two postoperative days. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective colorectal resection for benign or malignant disease
- surgery involves an anastomosis
- open or minimally invasive technique
- midline laparotomy used for specimen extraction
Key exclusion criteria (7 listed)
- under 19
- allergy/sensitivity to adhesives
- immunocompromised
- pregnant
- emergency surgery
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 |
|---|---|---|
| Incisional Negative Pressure Wound Therapy (iNPWT)Also: Surgical Incision Management System (SIMS), Closed Incisional Negative Pressure Wound Therapy (ciNPWT), V.A.C dressingIncisional Negative Pressure Wound Therapy devices are lightweight, self contained, portable battery powered (or line powered), suction pumps for medical procedures where secretions and other body fluids and infectious materials must be removed through the application of continuous or intermittent negative pressure. The pumps are operated through computer software, having help and alarm features. The device is indicted for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The pumps may be used at patient's bedside. These are suitable for use in either hospitals or long term care facilities and nursing homes. These devices will be applied to closed laparotomy incisions with the aim to provide three days of continuous negative pressure of - 100mmHg. | Device | Incisional Negative Pressure Wound Therapy (iNPWT) |
| Sterile Gauze DressingAlso: Self-adhesive Absorbent DressingIn most cases, self-adhesive, absorbent dressings will be used for standard wound therapy. However, surgical teams may decide on alternative forms of sterile gauze dressings, as long as the wound site is kept clean and dry. Dressings should be taken down on the second post-operative day. | Device | Standard Therapy |
Primary outcome
Superficial Surgical Site Infection (SSI)
Time frame: 30 days post op
Infection occurring within the first thirty days after surgery with at least one of the following: 1) purulent drainage from the superficial incision; 2) organisms obtained from an aseptically obtained culture of tissue or fluid from the superficial incision; 3) at least one of the local signs of infection; 4) superficial incision deliberately opened by the surgeon (unless the culture is negative)
Wound Complication
Time frame: 30 days post op
At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption
5 secondary outcomes
Length of stay
Time frame: approximately 5-10 days on average
Wound-related visits post surgery
Time frame: 30 days post op
Need for and duration of home care
Time frame: 30 days post op
Blistering/reaction to wound dressings
Time frame: 3 days post op
Post Op Complications
Time frame: 30 days post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Individual participant dataSharing planned: Undecided. To be decided
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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.
Neely O.M. Panton, MD, FRCSC principal investigator
UBC Division of General Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Incisional Negative Pressure Wound Therapy (iNPWT) and Sterile Gauze Dressing in people with Surgical Site Infection and Wound Complication, run by University of British Columbia.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mitchell A. Webb, MD (778 242 9807, mitchell.webb@alumni.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superficial Surgical Site Infection (SSI) (time frame: 30 days post op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2016.