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The PRESSURE Trial


- candidate number27823
- NTR NumberNTR6675
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-sep-2017
- Secondary IDs NL60054.018 CCMO
- Public TitleThe PRESSURE Trial
- Scientific TitlePREventing Surgical Site occurrences using negative pressURE wound therapy?
-
The PRESSURE Trial
- ACRONYMPRESSURE
- hypothesisIncisional negative pressure wound therapy reduces the amount of patients with clinically relevant surgical site occurrences within 30 days after contaminated abdominal wall reconstruction.
- Healt Condition(s) or Problem(s) studiedHernia, Incisional hernia, Contamination, Surgical site infection, Postoperative wound complications
- Inclusion criteria• ≥18 years
• Informed consent
• Scheduled for elective, open abdominal wall reconstruction*
• Pre-operative CT available
And one of the following:
• A stoma or enterocutaneous fistula and an abdominal wall defect of >6 cm** on CT
• Violation of the gastrointestinal tract and an abdominal wall defect of >6 cm on CT
• Infected mesh (any size)
• Septic dehiscence (any size)
- Exclusion criteria• Patients <18
• Antibiotic treatment during the 7 days before surgery
• Parastomal hernias in which the stoma is not being relocated or taken down and the parastomal hernia is the only defect planned for reconstruction*
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2017
- planned closingdate1-apr-2020
- Target number of participants388
- InterventionsIncisional negative pressure wound therapy
- Primary outcomeThe percentage of patients with at least one clinically relevant surgical site occurrence (SSO) within 30 days after surgery.

Clinically relevant surgical site occurrences are defined as:

Surgical site infection
Wound cellulitis
Wound dehiscence
Enterocutaneous fistula
Seroma
Hematoma
Skin ischemia/necrosis

*A SSO is considered clinically relevant when the attending physician considers the SSO of being of such severity that it needs further action for purposes of clinical diagnosis (other than clinical examination) or treatment, such as ultrasound/CT, antibiotics, drainage or surgery. The term “attending physician” is interpreted to mean the surgeon(s), infectious disease specialist, other physician on the case, emergency physician or physician’s designee (nurse practitioner or physician’s assistant).
- Secondary outcome-QoL (EQ-5D-5L)
-Recurrence 1 year after surgery
-The individual components of primary outcome SSO at <30, <90, <1 year after surgery
-Peri-incisional SSO
-The percentage of patients with signs of SSO on photographs by blinded outcome assessment
-Frequency and type of procedures related to SSO
-Hospital stay after surgery in days
-Earlier removal of iNPWT because of SSO
-Emergency department visits after discharge
-Readmission within 30 days, 90 days and within a year for any complication
-30-day, 90-day, in-hospital and 1-year mortality
-Non-primary outcome complications (e.g. ileus, pneumonia)
-Cost-effectiveness (The Netherlands only)
- Timepoints30 days, 90 days, and one year after surgery
- Trial web sitepressuretrial.com
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD Candidate, BSc P.R. Zwanenburg
- CONTACT for SCIENTIFIC QUERIESPhD Candidate, BSc P.R. Zwanenburg
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Investigator initiated trial ( IIT )
- Publications
- Brief summarySUMMARY

Rationale & Objective:
With an incidence of up to 46% in contaminated abdominal wall reconstruction, surgical site occurrences (SSO) are an overly frequent problem in leading to significant morbidity and mortality. Evidence suggests incisional negative pressure wound therapy (iNPWT) reduces SSO in clean surgery. However, there is a paucity of RCTs describing usage of iNPWT in contaminated surgery. Therefore, we propose conducting this RCT with the hypothesis that iNPWT decreases the number of patients that develop SSO in contaminated abdominal wall reconstruction.

Study design:
An investigator-initiated, multinational, multicenter, pragmatic, randomized controlled trial with parallel group superiority design in our collaborative international network, randomizing 388 patients with a 1:1 ratio.

Study population:
In order to participate in this trial, a subject must meet the following criteria:
• ≥18 years
• Informed consent
• Scheduled for elective, open abdominal wall reconstruction
• Pre-operative CT available
And one of the following:
• A stoma or enterocutaneous fistula and a defect of >6 cm* in size on CT
• Violation of the gastrointestinal tract** and defect of >6 cm in size on CT
• Infected mesh (any size)
• Septic dehiscence (any size)
*In case of parastomal hernia and the patient is candidate for ostomy takedown or relocation, the resulting defect in the abdominal wall should be taken for this measure

Intervention:
In this trial, commercially available incisional negative pressure wound therapy will be compared with conventional wound care (defined as a simple, sterile, gauze based dressing as routinely used at the participating hospital site).

Main study endpoint:
The primary outcome is the number of patients with at least one surgical site occurrence (surgical site infection, wound dehiscence, enterocutaneous fistula, seroma, hematoma, skin or wound ischemia/necrosis) 30 days after surgery, with extended follow-up at 90 days and 1 year after surgery. The amount of distinct surgical site occurrence components (e.g. dehiscence) will be registered as secondary outcome as well. Other important secondary outcomes are QoL and hernia recurrence.
- Main changes (audit trail)
- RECORD6-sep-2017 - 15-sep-2017


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