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

NCT04735133 | Completed DMC

• 1 other identifier: TDK-2018-8406
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• surgical wound complications (SWC)

  surgical site infection, seroma, hematoma, wound dehiscence/evisceration

  postoperative 30th day

Secondary Outcomes (2)

• The ASEPSIS Wound Scoring System

  All participants will be followed up 4 times during a month (seven days, 15th, 21st, and 30th days

• length of stay in the hospital

  30days

Study Arms (2)

intervention grpup

EXPERIMENTAL

pNPWT device 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.

Device: pNBYT

control group

NO INTERVENTION

The wound of the control group was covered with a sterile gauze dressing. After the wound was left closed for 48 hours in the clinical routine, the surgical site was left open, supporting healing. Therefore, the dressing of the control group was removed after 48 hours, and the wound was left open. 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.

Interventions

pNBYT DEVICE

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.

intervention grpup

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Melikgazi, 38070, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36264751 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Sssistant (PhD)

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 2, 2021
• Study Start: November 18, 2018
• Primary Completion: November 18, 2019
• Study Completion: February 15, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)