NCT04735133

The Effect of Wound Problems Wound Dressing in Patients With Colorectal Cancer Surgery

The Effect of Surgical Wound Complications Profilactic Negative Pressure Wound Therapy in Patients With High Risk Colorectal Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Surgery
• Surgery--Complications
• Surgical Site Infection
• Wound Complication

Interventions

Type	Name	Description
DEVICE	pNBYT	pNPWT device (80mm Hg) was placed in the pNPWT group for seven days The incision area was evaluated during the first seven days, and on the 15th, 21st, and 30th days postoperatively for the presence of hematoma, seroma, wound dehiscence/evisceration, and SSI.

Timeline

• Start date: 2018-11-18
• Primary completion: 2019-11-18
• Completion: 2020-02-15
• First posted: 2021-02-02
• Last updated: 2021-02-02

Locations

1 site across 1 country: Turkey (Türkiye)