Clinical trial NCT04735133: The Effect of Wound Problems Wound Dressing in Patients With Colorectal Cancer Surgery
Official title: The Effect of Surgical Wound Complications Profilactic Negative Pressure Wound Therapy in Patients With High Risk Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Surgery
Surgery--Complications
Surgical Site Infection
Wound Complication
Keywords: colorectal cancer
colorectal surgery
surgical site infection
surgical wound complication
negative pressure wound therapy
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 ASEPSİS 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.

Detailed description: The effects of negative pressure wound treatment applied to high-risk patients after open colorectal cancer surgery on four SWCs, including surgical site infections, hematoma, seroma, and wound dehiscence, were studied. The study started before surgery and lasted up to one month after surgery.

Preoperatively, patients fasted for eight hours before the operation and were required to take a shower with 2% chlorhexidine gluconate at night. The patients who required surgical hair removal were shaved with a clipper in the operating room before the operation. Also, patients received 1g of ampicillin + sulbactam/cefazolin within 60 minutes before the incision.

Eligibility criteria: 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:

-

Primary outcomes:
measure: surgical wound complications (SWC)
timeFrame: postoperative 30th day
Secondary outcomes:
measure: The ASEPSIS Wound Scoring System
timeFrame: All participants will be followed up 4 times during a month (seven days, 15th, 21st, and 30th days
measure: length of stay in the hospital
timeFrame: 30days
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Melikgazi
Study officials:
References:
citation: Kacmaz HY, Baser M, Sozuer EM. Effect of Prophylactic Negative-Pressure Wound Therapy for High-Risk Wounds in Colorectal Cancer Surgery: A Randomized Controlled Trial. Adv Skin Wound Care. 2022 Nov 1;35(11):597-603. doi: 10.1097/01.ASW.0000874168.60793.10.