<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02967627</url>
  </required_header>
  <id_info>
    <org_study_id>H16-02565</org_study_id>
    <nct_id>NCT02967627</nct_id>
  </id_info>
  <brief_title>VAC Dressings for Colorectal Resections</brief_title>
  <acronym>VACCRR</acronym>
  <official_title>Incisional Negative Pressure Wound Therapy Following Colorectal Resection: a Single Site, Prospective, Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical Site Infections (SSIs) and wound complications are common occurrences following&#xD;
      colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has&#xD;
      developing evidence for improving wound complication rates in certain populations. However,&#xD;
      there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We&#xD;
      propose a study in which patients are randomized into one of two treatment arms: 1)&#xD;
      incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30&#xD;
      days for diagnosis of infection or wound complication. We will compare primary outcomes in&#xD;
      each group using Chi-Squared statistical testing in order to report a Absolute Risk Reduction&#xD;
      and Number Needed to Treat&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To evaluate if incisional Negative Pressure Wound Therapy (iNPWT) confers a lower&#xD;
      rate of Surgical Site Infection (SSI) or wound complication compared to standard treatment of&#xD;
      elective colorectal resection laparotomies.&#xD;
&#xD;
      Justification: Colorectal resection with bowel anastomosis is a clean-contaminated procedure&#xD;
      known to have increased rates wound complication. Techniques like the use of incisional wound&#xD;
      barriers, antimicrobial eluding dressings or iodine washout have been assessed in an attempt&#xD;
      to reduce occurrence. However, evidence for their efficacy is not compelling for surgeons to&#xD;
      universally adapt. Meanwhile, negative pressure wound therapy has demonstrated impressive&#xD;
      efficacy in the management of complex and non-healing wounds. And recently, NPWT has become&#xD;
      an area of interest in managing, not only open wounds, but closed wounds as well. The benefit&#xD;
      of this therapy is yet to be clearly defined in the elective colorectal resection patient&#xD;
      population, however.&#xD;
&#xD;
      Null hypothesis: There is no difference in SSI or wound complication rate in standard and&#xD;
      iNPWT groups.&#xD;
&#xD;
      Design: Single-institution, prospective, randomized, open-label, superiority trial&#xD;
&#xD;
      Statistical Analysis: Assuming a complication rate of 20-30% and a relative risk reduction of&#xD;
      50%, we will recruit 400 patients (200 in each group) to achieve a power of 80% and type 1&#xD;
      error of 0.05. Primary endpoints will be: Wound Complication - defined as presence of seroma,&#xD;
      hematoma, dehiscence, SSI - and SSI reported independently. Secondary endpoints will include:&#xD;
      Length of Stay, ER visits related to SSI, Complications (according to Clavien-Dindo&#xD;
      classification), need for and duration of home care related to wound care, and wound VAC&#xD;
      specific complications (local reaction to adhesive dressing, blisters, failure of vacuum,&#xD;
      need for early removal). Primary endpoints will be assessed according to intention-to-treat&#xD;
      principle using Pearson's chi-squared test. In the event that baseline characteristics are&#xD;
      significantly different, a secondary analysis using multivariable logistic regression will&#xD;
      adjust for the effect of the difference. A p value of &lt; 0.05 will be used to determine&#xD;
      significance. Results will be presented as an absolute risk reduction as well as number&#xD;
      needed to treat to prevent one wound complication. Secondary outcomes will be compared using&#xD;
      a Mann-Whitney U-test for non-normally distributed continuous variables and chi-squared for&#xD;
      categorical data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Superficial Surgical Site Infection (SSI)</measure>
    <time_frame>30 days post op</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wound Complication</measure>
    <time_frame>30 days post op</time_frame>
    <description>At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>approximately 5-10 days on average</time_frame>
    <description>Number of days spent in hospital post op</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound-related visits post surgery</measure>
    <time_frame>30 days post op</time_frame>
    <description>Number of wound-related visits to primary care physician, nurse practitioner, or emergency for concerns related to laparotomy incision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for and duration of home care</measure>
    <time_frame>30 days post op</time_frame>
    <description>Did the patient require home care nursing for wound care? If so, how many visits?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blistering/reaction to wound dressings</measure>
    <time_frame>3 days post op</time_frame>
    <description>Did the patient develop skin blisters or hypersensitivity reaction secondary to their wound dressings?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Op Complications</measure>
    <time_frame>30 days post op</time_frame>
    <description>Did the patient develop any major complications - as according to Clavien-Dindo classification?</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Surgical Site Infection</condition>
  <condition>Wound Complication</condition>
  <condition>Wound Dehiscence</condition>
  <condition>Seroma</condition>
  <condition>Hematoma</condition>
  <arm_group>
    <arm_group_label>Incisional Negative Pressure Wound Therapy (iNPWT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Incisional Negative Pressure Wound Therapy (iNPWT)</intervention_name>
    <description>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.</description>
    <arm_group_label>Incisional Negative Pressure Wound Therapy (iNPWT)</arm_group_label>
    <other_name>Surgical Incision Management System (SIMS)</other_name>
    <other_name>Closed Incisional Negative Pressure Wound Therapy (ciNPWT)</other_name>
    <other_name>V.A.C dressing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sterile Gauze Dressing</intervention_name>
    <description>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.</description>
    <arm_group_label>Standard Therapy</arm_group_label>
    <other_name>Self-adhesive Absorbent Dressing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective colorectal resection for benign or malignant disease&#xD;
&#xD;
          -  surgery involves an anastomosis&#xD;
&#xD;
          -  open or minimally invasive technique&#xD;
&#xD;
          -  midline laparotomy used for specimen extraction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 19&#xD;
&#xD;
          -  allergy/sensitivity to adhesives&#xD;
&#xD;
          -  immunocompromised&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  elective surgery&#xD;
&#xD;
          -  additional procedures performed at time of surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neely O.M. Panton, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>UBC Division of General Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mitchell A. Webb, MD</last_name>
    <phone>778 242 9807</phone>
    <email>mitchell.webb@alumni.ubc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vy Nguyen, MD, FRCSC</last_name>
    <phone>604 875 4063</phone>
    <email>v.nguyen86@gmail.com</email>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Hematoma</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>To be decided</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02967627
org study id: H16-02565
nct id: NCT02967627
lead sponsor: 
has dmc: Yes
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Superficial Surgical Site Infection (SSI)
time frame: 30 days post op
description: 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)
measure: Wound Complication
time frame: 30 days post op
description: At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption
measure: Length of stay
time frame: approximately 5-10 days on average
description: Number of days spent in hospital post op
measure: Wound-related visits post surgery
time frame: 30 days post op
description: Number of wound-related visits to primary care physician, nurse practitioner, or emergency for concerns related to laparotomy incision.
measure: Need for and duration of home care
time frame: 30 days post op
description: Did the patient require home care nursing for wound care? If so, how many visits?
measure: Blistering/reaction to wound dressings
time frame: 3 days post op
description: Did the patient develop skin blisters or hypersensitivity reaction secondary to their wound dressings?
measure: Post Op Complications
time frame: 30 days post op
description: Did the patient develop any major complications - as according to Clavien-Dindo classification?
arm group label: Incisional Negative Pressure Wound Therapy (iNPWT)
arm group type: Experimental
description: 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.
arm group label: Standard Therapy
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: Incisional Negative Pressure Wound Therapy (iNPWT)
description: 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.
arm group label: Incisional Negative Pressure Wound Therapy (iNPWT)
other name: Surgical Incision Management System (SIMS)
other name: Closed Incisional Negative Pressure Wound Therapy (ciNPWT)
other name: V.A.C dressing
intervention type: Device
intervention name: Sterile Gauze Dressing
description: 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.
arm group label: Standard Therapy
other name: Self-adhesive Absorbent Dressing
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Neely O.M. Panton, MD, FRCSC
role: Principal Investigator
affiliation: UBC Division of General Surgery
last name: Mitchell A. Webb, MD
phone: 778 242 9807
email: mitchell.webb@alumni.ubc.ca
last name: Vy Nguyen, MD, FRCSC
phone: 604 875 4063
email: v.nguyen86@gmail.com
responsible party type: Sponsor
mesh term: Surgical Wound Infection
mesh term: Hematoma
mesh term: Wounds and Injuries
sharing ipd: Undecided
ipd description: To be decided