The aim of our study is to investigate whether NPWT in closed incisional wounds decreases the rate of SSI, in patients undergoing laparoscopic or open colorectal surgery with a minimal incisional length of 30mm. Primary Objective: The primary…
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the incidence of incisional SSI within 30 days of
surgery. In accordance with Centre for Disease Control and Prevention (CDC) and
National Healthcare Safety Network (NHSN) SSI is defined as (24, 25) as:
Superficial incisional SSI
Infection occurs within 30 days after surgery and infection involves only skin
or subcutaneous tissue of the incision and at least one of the following:
1. Purulent drainage, with or without laboratory confirmation, from the
superficial incision.
2. Organisms isolated from an aseptically obtained culture of fluid or tissue
from the superficial incision.
3. At least one of the following signs or symptoms of infection: pain or
tenderness, localized swelling, redness, or heat and superficial incision is
deliberately opened by surgeon, unless incision is culture-negative.
4. Diagnosis of superficial incisional SSI by the surgeon or attending
physician.
Deep incisional SSI
Infection occurs within 30 days after surgery if no implant is left in place or
within 1 year if implant is in place and the infection appears to be related to
the operation and Infection involves deep soft tissues (eg fascial and muscle
layers) of the incision and at least 1 of the following:
1. Purulent drainage from the deep incision but not from the organ/space
component of the surgical site.
2. A deep incision spontaneously dehisces or is deliberately opened by a
surgeon when the patient has at least one of the following signs or symptoms:
fever (>38.0°C), localized pain, or tenderness, unless site is culture-negative.
3. An abscess or other evidence of infection involving the deep incision is
found on direct examination, during reoperation, or by histopathologic or
radiologic examination.
4. Diagnosis of a deep incisional SSI by a surgeon or attending physician.
Secondary outcome
• QoL
QoL will be assessed using the SF36 and EQ-5D-5L questionnaire, which will be
conducted at admission, day 30 and day 365 postoperatively.
• Postoperative complications
All postoperative complications will be recorded in the Case Reporting Form
(CRF) including date of occurrence, diagnosis procedure and treatment.
• Cost
Cost will be considered the analysis of the device*s cost versus the
effectiveness of its usage by decreasing the incidence of the SSI. Reduction in
health related problems as a consequence will economically be analysed at day
30 and day 365 postoperatively using the SF-HLQ questionnaire.
• Cosmesis
Cosmesis will be assessed 365 days after the surgery by complying the POSAS
questionnaire from the patient and the observer(26).
Background summary
Surgical site infection (SSI) following abdominal surgery is considered one of
the most significant and frequent complications resulting in mortality,
morbidity, and costs(1-3). In previous literature it has been indicated that
SSI significantly increases length of hospital stay, morbidity and induces
psychological effects.
Through time, surgeons have explored different interventions to decrease the
SSI rate, beyond pre-operative antibiotic prophylaxis and aseptic techniques.
Negative pressure wound therapy (NPWT) was reported for the first time in 1997,
as a novel technique, by Argenta et al. which brought a revolution in treating
chronic and other difficult-to-manage wounds(4). Usage of NPWT is now a widely
accepted therapy for secondarily healing wounds and nowadays the application of
NPWT to surgical incision healing by primary intention is a subject undergoing
intense study in different disciplines(5-7). Beside a decrease in SSI rate,
decreases in serous exudative rates and good healing of incisions
post-operatively have also been reported(5, 6). Blackham et al. performed a
retrospective analysis of 191 operations for colorectal, pancreatic, or
peritoneal surface malignancies, and found a decrease of SSI in the group using
NPWT versus the control group (6.0% vs 27.4%, P = .001) (8). Bonds et al.
showed the same results in a retrospective cohort study, where a significant
difference was reported in SSI incidence between NPWT group and the ones
undergoing standard closure (12.5% versus 29.3%)(9).
More than two decades after its introduction, laparoscopic approach has become
the standard of care for colorectal surgery(10). The feasibility and advantages
of laparoscopic approach have been well documented(11). Despite prophylactic
and sterility measures implemented pre- per- and post-intervention,
(preoperative antibiotic use and aseptic operative technique) SSI rates
following laparoscopic colorectal surgery remain high and vary from 4% to
16.7%(12-18). Given the significant patient morbidity associated with this
complication, this field represent a significant research gap with priority
need for future studies.
Study objective
The aim of our study is to investigate whether NPWT in closed incisional wounds
decreases the rate of SSI, in patients undergoing laparoscopic or open
colorectal surgery with a minimal incisional length of 30mm.
Primary Objective: The primary objective is to determine the reduction of SSI
by NPWT for closed incisional wounds.
Secondary Objectives: The secondary objective is to evaluate the QoL,
postoperative complications, cost and cosmesis.
Study design
The CONTACT trial is a randomized controlled trial (RCT), designed as an
European, multicenter, open-label, superiority trial, in which the efficacy and
effectiveness of the NPWT in closed wounds will be assessed in preventing SSI.
The study will have a 1-year follow-up where the development of SSI, QoL,
post-operative complications, cosmesis and cost will be evaluated.
Intervention
NPWT especially designed for closed wounds under the brand name Pico* is the
investigational product in this study. Its features include a single-patient
use continuous vacuum system set to 80 mm Hg, connected to the sponge dressing,
placed under sterile conditions in the operating room and would be maintained 7
consecutive days after the surgery.
The control group is going to receive SSD, which is the standard practice for
incisional wounds after colorectal surgery covering laparoscopy or laparotomy
incision. The SSD will be changed according to the standard protocol and
routine of care for each site.
Study burden and risks
Based on previous studies and clinical experience, a relative reduction of the
SSI rate by 50% is expected in the patients using the NPWT device.
If the usage of the NPWT device leads to unexpected complications that have
large influence on the patient*s well being early termination should be taken
into consideration. However, previous studies in other disciplines showed that
the usage of the device is safe and there is no major complication related to
its usage(28-30). NPWT devices are widely used products in surgery, so we do
not expect any problems of such an impact. In case the study is ended
prematurely, the coordinating PI will notify the accredited METC and the
competent authority within 15 days, including the reasons for the premature
termination.
Dr. Molewaterplein 40
Rotterdam 3000CA
NL
Dr. Molewaterplein 40
Rotterdam 3000CA
NL
Listed location countries
Age
Inclusion criteria
Patients >= 18 years old, undergoing laparoscopic or open colorectal surgery and
have 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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68929.078.19 |
| OMON | NL-OMON23267 |