Clinical trial NCT04088162: The Use of Post-operative NPWT Dressing in the Prevention of Infectious Complications After Ostomy Reversal Surgery
Official title: The Use of Post-operative Negative Pressure Wound Therapy (NPWT) Dressing in the Prevention of Wound Healing Problems and Infectious Complications After Ostomy Reversal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Surgical Wound
Negative Pressure Wound Therapy
Postoperative Wound Infection
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 .


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of wound management complications
timeFrame: 90 days
measure: Incidence of wound management complications in groups treated with different types of postopNPWT
timeFrame: 90 days
Secondary outcomes:
measure: Surgical Site Infections (SSI) Incidence
timeFrame: 90 days
measure: Postoperative Hospital Stay (LOS)
timeFrame: 90 days
measure: Complete wound healing (CWH) time
timeFrame: 90 Days
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Oddział kliniczny chirurgii ogólnej, endokrynologicznej i onkologii gastroenterologicznej
state: Wielkopolska
city: Kraków
country: Poland
facility: 2nd Department of General Surgery, Jagiellonian University
Study officials:
References:
citation: Wierdak M, Pisarska-Adamczyk M, Wysocki M, Major P, Kolodziejska K, Nowakowski M, Vongsurbchart T, Pedziwiatr M. Prophylactic negative-pressure wound therapy after ileostomy reversal for the prevention of wound healing complications in colorectal cancer patients: a randomized controlled trial. Tech Coloproctol. 2021 Feb;25(2):185-193. doi: 10.1007/s10151-020-02372-w. Epub 2020 Nov 7.