Clinical trial NCT02967627: VAC Dressings for Colorectal Resections
Official title: Incisional Negative Pressure Wound Therapy Following Colorectal Resection: a Single Site, Prospective, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Site Infection
Wound Complication
Wound Dehiscence
Seroma
Hematoma
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Superficial Surgical Site Infection (SSI)
timeFrame: 30 days post op
measure: Wound Complication
timeFrame: 30 days post op
Secondary outcomes:
measure: Length of stay
timeFrame: approximately 5-10 days on average
measure: Wound-related visits post surgery
timeFrame: 30 days post op
measure: Need for and duration of home care
timeFrame: 30 days post op
measure: Blistering/reaction to wound dressings
timeFrame: 3 days post op
measure: Post Op Complications
timeFrame: 30 days post op
Other outcomes:
Locations:
Study officials:
affiliation: UBC Division of General Surgery
name: Neely O.M. Panton, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: