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

Primary Purpose

Colorectal Cancer, Surgery, Surgery--Complications

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pNBYT
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colorectal cancer, colorectal surgery, surgical site infection, surgical wound complication, negative pressure wound therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Erciyes University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention grpup

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

surgical wound complications (SWC)
surgical site infection, seroma, hematoma, wound dehiscence/evisceration

Secondary Outcome Measures

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.
length of stay in the hospital

Full Information

First Posted
January 26, 2021
Last Updated
January 30, 2021
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT04735133
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention grpup
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
pNBYT
Intervention Description
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.
Primary Outcome Measure Information:
Title
surgical wound complications (SWC)
Description
surgical site infection, seroma, hematoma, wound dehiscence/evisceration
Time Frame
postoperative 30th day
Secondary Outcome Measure Information:
Title
The ASEPSIS Wound Scoring System
Description
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.
Time Frame
All participants will be followed up 4 times during a month (seven days, 15th, 21st, and 30th days
Title
length of stay in the hospital
Time Frame
30days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: -
Facility Information:
Facility Name
Erciyes University
City
Kayseri
State/Province
Melikgazi
ZIP/Postal Code
38070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36264751
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.
Results Reference
derived

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

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