VAC Dressings for Colorectal Resections
VACCRR
Incisional Negative Pressure Wound Therapy Following Colorectal Resection: a Single Site, Prospective, Randomized Control Trial
1 other identifier
interventional
400
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 16, 2016
CompletedFirst Posted
Study publicly available on registry
November 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedNovember 18, 2016
November 1, 2016
10 months
November 16, 2016
November 17, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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)
30 days post op
Wound Complication
At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption
30 days post op
Secondary Outcomes (5)
Length of stay
approximately 5-10 days on average
Wound-related visits post surgery
30 days post op
Need for and duration of home care
30 days post op
Blistering/reaction to wound dressings
3 days post op
Post Op Complications
30 days post op
Study Arms (2)
Incisional Negative Pressure Wound Therapy (iNPWT)
EXPERIMENTALPatients 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 COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- elective colorectal resection for benign or malignant disease
- surgery involves an anastomosis
- open or minimally invasive technique
- midline laparotomy used for specimen extraction
You may not qualify if:
- under 19
- allergy/sensitivity to adhesives
- immunocompromised
- pregnant
- emergency surgery
- elective surgery
- additional procedures performed at time of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neely O.M. Panton, MD, FRCSC
UBC Division of General Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2016
First Posted
November 18, 2016
Study Start
November 1, 2016
Primary Completion
September 1, 2017
Study Completion
October 1, 2017
Last Updated
November 18, 2016
Record last verified: 2016-11