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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04088162
Other study ID # JagiellonianU-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date January 1, 2021

Study information

Verified date September 2019
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: Although negative-pressure wound therapy (NPWT) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear. We performed a Randomized Control Trial to assess the usefulness of postoperative NPWT in reduction of postoperative wound healing complications and surgical site infections after diverting ileostomy closure, in the group of patients previously operated for colorectal resection due to cancer. Materials & Methods: Prospective, randomized study will be conducted. Patients with past history of colorectal cancer laparoscopic surgery with protective loop ileostomy scheduled to undergo ileostomy closure with primary wound closure will be randomly divided into groups with or without NPWT. The primary endpoint are incidence of wound related complications (WRC) (wound healing complications witch required surgical intervention other than suture removal or dressing changing). The secondary endpoints are incidences of Surgical Site Infection (SSI) and length of postoperative hospital stay (LOS) and length of complete wound healing (CWH). Cost analysis will also be performed. In first step of this study between January 2016 and December 2018 we will asses the usefulness of one of the NPWT devices (NANOVA KCI) in prevention of WHC in established group. The second part of the study will be performed in 2 centers between January 2019 and December 2021. In this step we want to compere other NPWT devices in the same application and to confirm single center outcomes .


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients aged 18 or older - Previous colorectal resection with the formation of protective ileostomy due to cancer - Ileostomy closure surgery as an elective procedure. Exclusion Criteria: - Emergency or urgent operation - Active infection - Other than ileostomy closure or parastomal hernioplasty operation performed. - Patents who within 1 week after operation will be re-operated or transferred to Intensive Care Unit or other hospital word due to noninfectious complications

Study Design


Intervention

Device:
Postoperative Negative Pressure Wound Therapy KCI NANOVA


Locations

Country Name City State
Poland 2nd Department of General Surgery, Jagiellonian University Kraków
Poland Oddzial kliniczny chirurgii ogólnej, endokrynologicznej i onkologii gastroenterologicznej Poznan Wielkopolska

Sponsors (1)

Lead Sponsor Collaborator
Michal Pedziwiatr

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of wound management complications Primary endpoint is described as a reduction of wound healing complications (WHC) after protective ostomy closure in a group of patients previously operated for colorectal cancer with protective ileostomy formation. Wound healing complications are described as any condition of wound which required postoperative intervention other than change of dressing or removing of sutures . 90 days
Primary Incidence of wound management complications in groups treated with different types of postopNPWT The primary endpoint is described as a comparison of reduction of wound healing complications (WHC) after protective ostomy closure in a group of patients previously operated for colorectal cancer with protective ileostomy formation between 3 different postopNPWT devices (KCI NANOVA, Smith&Naphiew PICO and Gynadyne XLR 8) . Wound healing complications are described as any condition of wound which required postoperative intervention other than change of dressing or removing of sutures . 90 days
Secondary Surgical Site Infections (SSI) Incidence Secondary endpoints is described as incidence of SSI. Incisional SSI diagnosis criteria included an infection that occurred within 30 days after the operation involving the skin, subcutaneous tissue, or deep soft tissue (e.g. fascia and muscle layers) at the incision site, organ or space according to the criteria of CDC and ECDC for diagnosis of SSI 90 days
Secondary Postoperative Hospital Stay (LOS) Secondary endpoints is described as postoperative length of hospital stay (LOS) 90 days
Secondary Complete wound healing (CWH) time Secondary endpoints is described as the duration of complete wound healing (CWH). Complete wound healing was defined as complete closure of the wound without any discharge at the outpatient clinic or reported by patient. 90 Days
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