Colorectal Cancer Clinical Trial
Official title:
The Effect of Surgical Wound Complications Profilactic Negative Pressure Wound Therapy in Patients With High Risk Colorectal Cancer Surgery
Verified date | January 2021 |
Source | TC Erciyes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was conducted as a randomized controlled trial in order to determine the effect of prophylactic negative pressure wound therapy for the prevention of surgical site complications in high-risk colorectal cancer surgery. Hypothesis: Prophylactic negative pressure wound therapy applied after open colorectal cancer surgery to high-risk patients affects surgical wound complications. pNBYT group: The study was completed with a total of 50 patients, 24 of intervention group anda 26 of the control group, who met the inclusion criteria at the surgical oncology service of a university hospital. The data were collected using Patient Identification Form, Surgical Procedure Form, Wound Follow-up Chart and ASEPSÄ°S Wound Scoring System. Ethics committee approval and written informed consent of the individuals was taken in the research. The data were analyzed in SPSS Statistics 24.0 program using Shapiro Wilk test and Q-Q graphs, Independent Sample t test, Mann Whitney U test, Chi-square, Cochran's Q and Friedman test. The value of p<0.05 was accepted for the statistical significance level. It was determined that the groups were similar in terms of identification and surgical procedure characteristics.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 15, 2020 |
Est. primary completion date | November 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: Patients undergoing open colorectal cancer surgery, clean-contaminated (Class-II) or contaminated (Class-III) wounds, ASA 2, 3, or 4, and fulfilling at least one of the following criteria were included: - 75 years old and above, - Chronic disease such as Diabetes (DM), Chronic obstructive pulmonary disease (COPD), Heart failure (Ejection fraction = 40%), Preoperative anemia (Hb=10mg/dl), - Nutritional problems (BMI 30 kg / m2 and over, malnutrition (NRS 2002 score 3 and over or albumin=3 mg/dl), - Regular steroids or anticoagulants, - Neoadjuvant chemotherapy and radiotherapy. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Turkey | Erciyes University | Kayseri | Melikgazi |
Lead Sponsor | Collaborator |
---|---|
TC Erciyes University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | surgical wound complications (SWC) | surgical site infection, seroma, hematoma, wound dehiscence/evisceration | postoperative 30th day | |
Secondary | The ASEPSIS Wound Scoring System | is a quantitative scoring method that provides a numerical value regarding the severity of the SSI by using objective criteria based on the appearance of the wound. The wound score is categorized into five stages: 0-10 points are considered satisfactory healing, 11-20 points disturbance of healing, 21-30 points minor wound infection, 31-40 points moderate wound infection, and =41 points severe wound infection. | All participants will be followed up 4 times during a month (seven days, 15th, 21st, and 30th days | |
Secondary | length of stay in the hospital | 30days |
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