Surgical Site Infection Clinical Trial
— VACCRROfficial 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
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | October 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of British Columbia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | Wound Complication | At least one of the following: 1) seroma; 2) hematoma; 3) SSI; 4) wound dehiscence/disruption | 30 days post op | No |
Secondary | Length of stay | Number of days spent in hospital post op | approximately 5-10 days on average | No |
Secondary | Wound-related visits post surgery | Number of wound-related visits to primary care physician, nurse practitioner, or emergency for concerns related to laparotomy incision. | 30 days post op | No |
Secondary | Need for and duration of home care | Did the patient require home care nursing for wound care? If so, how many visits? | 30 days post op | No |
Secondary | Blistering/reaction to wound dressings | Did the patient develop skin blisters or hypersensitivity reaction secondary to their wound dressings? | 3 days post op | No |
Secondary | Post Op Complications | Did the patient develop any major complications - as according to Clavien-Dindo classification? | 30 days post op | No |
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