Surgical Site Infection Clinical Trial
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
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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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