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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735133
• Other study ID #: TDK-2018-8406
• Status: Completed
• Phase: N/A
• Start date: November 18, 2018
• Est. completion date: February 15, 2020

Study information

• Verified date: January 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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:

-

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Surgery
• Surgery--Complications
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Complication
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

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