No registrations found.
ID
Source
Brief title
Health condition
Closed incision surgical site infection after colorectal surgery.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the occurrence of a surgical site infection in respectively the control and study groups at any time up to 30 days, with margin of 5 days, after surgery.
Secondary outcome
Secondarily quality of life as assessed through the VAS Pain and EQ-5D-5L questionnaires, cost, number of complications (overall and per type of complication) and cosmetic satisfaction will also be assessed.
Background summary
Rationale: Surgical site infection (SSI) following abdominal surgery is considered one of the
most significant and frequent complications resulting in mortality, morbidity, and costs.
Objective: Reduction of surgical site infection. Secondary objectives include assessment of
quality of life (QoL), post-operative complications, wound cosmesis and cost-effectiveness of
using negative pressure wound therapy (NPWT) device.
Study design: European Multicenter, open-label, randomized controlled trial.
Study population: Patients aged 18 years and older, undergoing laparoscopic or open
colorectal surgery
Intervention: Patients will be asked for informed consent, and will receive NPWT dressing in
the study group, and standard surgical dressing (SSD) in the control group.
Main study parameters/endpoints: The primary study endpoint is clinically assessed surgical
site infection.
Nature and extent of the burden and risks associated with participation, benefit and
group relatedness: The extent of the burden and risks associated participation could be
considered as small. The invasive procedure performed on behalf of the CONTACT trial is
usage of NPWT dressing performed at the operating theatre under sterile conditions. Previous
studies in other disciplines have shown superiority of NPWT in preventing surgical site
infections. No major risk of the device have been reported since it is used in other disciplines,
however patients might experience discomfort, hematomas and allergic reaction to the
materials composing the device.
Study objective
Negative pressure wound therapy reduces surgical site infections after colorectal surgery.
Study design
Occurence of surgical site infections up to 30 days and quality of life, cosmetic satisfaction of the woundhealing and (in)direct costs of the treatment one year after surgery.
Intervention
Application of negative pressure wound therapy (PICO 7 device) on closed surgical incisional wounds.
Inclusion criteria
Patients ≥ 18 years old
Patients undergoing laparoscopic or open colorectal surgery
The ability to understand and willing to sign the written informed consent.
Exclusion criteria
Pregnancy
Patients with known allergies to the adhesive materials that would be used
Perineal wounds
Perioperative HIPEC treatment
Purse-string suture
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9287 |
| CCMO | NL68929.078.19 |
| OMON | NL-OMON55599 |