search
Back to results

VAC Dressings for Colorectal Resections (VACCRR)

Primary Purpose

Surgical Site Infection, Wound Complication, Wound Dehiscence

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Incisional Negative Pressure Wound Therapy (iNPWT)
Sterile Gauze Dressing
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Site Infection

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • elective colorectal resection for benign or malignant disease
  • surgery involves an anastomosis
  • open or minimally invasive technique
  • midline laparotomy used for specimen extraction

Exclusion Criteria:

  • under 19
  • allergy/sensitivity to adhesives
  • immunocompromised
  • pregnant
  • emergency surgery
  • elective surgery
  • additional procedures performed at time of surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Incisional Negative Pressure Wound Therapy (iNPWT)

    Standard Therapy

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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)
    Wound Complication
    At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption

    Secondary Outcome Measures

    Length of stay
    Number of days spent in hospital post op
    Wound-related visits post surgery
    Number of wound-related visits to primary care physician, nurse practitioner, or emergency for concerns related to laparotomy incision.
    Need for and duration of home care
    Did the patient require home care nursing for wound care? If so, how many visits?
    Blistering/reaction to wound dressings
    Did the patient develop skin blisters or hypersensitivity reaction secondary to their wound dressings?
    Post Op Complications
    Did the patient develop any major complications - as according to Clavien-Dindo classification?

    Full Information

    First Posted
    November 16, 2016
    Last Updated
    November 17, 2016
    Sponsor
    University of British Columbia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02967627
    Brief Title
    VAC Dressings for Colorectal Resections
    Acronym
    VACCRR
    Official Title
    Incisional Negative Pressure Wound Therapy Following Colorectal Resection: a Single Site, Prospective, Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of British Columbia

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Site Infection, Wound Complication, Wound Dehiscence, Seroma, Hematoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Incisional Negative Pressure Wound Therapy (iNPWT)
    Arm Type
    Experimental
    Arm 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 Title
    Standard Therapy
    Arm Type
    Active Comparator
    Arm 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(s)
    Incisional Negative Pressure Wound Therapy (iNPWT)
    Other Intervention Name(s)
    Surgical Incision Management System (SIMS), Closed Incisional Negative Pressure Wound Therapy (ciNPWT), V.A.C dressing
    Intervention 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.
    Intervention Type
    Device
    Intervention Name(s)
    Sterile Gauze Dressing
    Other Intervention Name(s)
    Self-adhesive Absorbent Dressing
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Superficial Surgical Site Infection (SSI)
    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)
    Time Frame
    30 days post op
    Title
    Wound Complication
    Description
    At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption
    Time Frame
    30 days post op
    Secondary Outcome Measure Information:
    Title
    Length of stay
    Description
    Number of days spent in hospital post op
    Time Frame
    approximately 5-10 days on average
    Title
    Wound-related visits post surgery
    Description
    Number of wound-related visits to primary care physician, nurse practitioner, or emergency for concerns related to laparotomy incision.
    Time Frame
    30 days post op
    Title
    Need for and duration of home care
    Description
    Did the patient require home care nursing for wound care? If so, how many visits?
    Time Frame
    30 days post op
    Title
    Blistering/reaction to wound dressings
    Description
    Did the patient develop skin blisters or hypersensitivity reaction secondary to their wound dressings?
    Time Frame
    3 days post op
    Title
    Post Op Complications
    Description
    Did the patient develop any major complications - as according to Clavien-Dindo classification?
    Time Frame
    30 days post op

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: elective colorectal resection for benign or malignant disease surgery involves an anastomosis open or minimally invasive technique midline laparotomy used for specimen extraction Exclusion Criteria: under 19 allergy/sensitivity to adhesives immunocompromised pregnant emergency surgery elective surgery additional procedures performed at time of surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mitchell A. Webb, MD
    Phone
    778 242 9807
    Email
    mitchell.webb@alumni.ubc.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vy Nguyen, MD, FRCSC
    Phone
    604 875 4063
    Email
    v.nguyen86@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neely O.M. Panton, MD, FRCSC
    Organizational Affiliation
    UBC Division of General Surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    To be decided

    Learn more about this trial

    VAC Dressings for Colorectal Resections

    We'll reach out to this number within 24 hrs