Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University
About this trial
The goal of this clinical trial is to investigate Negative Pressure Wound Therapy (NPWT) in adults undergoing emergency laparotomy. The main question it aims to answer is:
Does NPWT decrease wound complications?
Researchers will compare it against regular dressings to see if NPWT is superior.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Written informed consent
>10 cm midline incision with primary skin closure
Emergency laparotomy
Disqualifiers
Not able to consent (e.g. dementia, impaired cognitive function, unconscious)
Subjects not possible to follow up as assessed by the Investigator
Allergy to dressing material
Pregnancy or breastfeeding (females of childbearing potential)
Trial design
Design model
Parallel
Treatments tested in this trial
Negative pressure wound therapy
DeviceAvance Solo Negative Pressure Wound Therapy (NPWT) System is a portable battery powered single use negative pressure system, suitable for use in closed incision and chronic wound indications. The system consists of Avance Solo Pump, Avance Solo Canister 50 mL, Avance Solo Border Dressing and Avance Solo Foam.
Standard postoperative dressing
DeviceMepilex Border Post-Op is a self-adhesive absorbent surgical dressing designed for exuding wounds. It is intended for acute wounds, such as surgical wounds, cuts and abrasions.
Treatment groups
720 Participants
are divided into 2 treatment groupsGroup A: Investigational deviceExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wound complications
Incident rate of wound complications (infection, dehiscence, seroma)
Time frame
14 and 30 daysSecondary outcomes
1
Surgical site infections
Time frame
14 and 30 days2
Wound dehiscence
Rupture of skin or fascia assessed clinically or with radiology.
Time frame
14 and 30 days3
Length of stay
Time frame
30 days4
Quality of life survey
EuroQoL Scale with 5 dimensions and 5 levels (EQ5D-5L). Patients scores in each dimension and total score indexed score is calculated where higher is better quality of life. Scores are weighted using published population values where 1 equals full health and worse health states goes towards, but can not reach 0. The EQ5D-5L also includes a VAS scale 0-100 where 100 is the best imaginable health and 0 the worst.
Time frame
30 days and 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala University
Lead sponsor
Uppsala County Council, Sweden
Collaborator
Dalarna County Council, Sweden
Collaborator
Sormland County Council, Sweden
Collaborator
Ostergotland County Council, Sweden
Collaborator
Västmanland County Council, Sweden
Collaborator
Landstingens Ömsesidiga Försäkringsbolag (Löf)
Collaborator
Source ClinicalTrials.gov