Surgical Incision, Wound Dehiscence, Surgical Site Infection, Incisional Hernia, Quality of Life
Conditions
Keywords
emergency surgery, negative pressure wound therapy, randomised controlled trial
Brief summary
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.
Detailed description
Negative Pressure Wound Therapy (NPWT) is a method of treating wounds using suction. The dressing is airtight, and the pump creates subatmospheric pressure, clearing the wound of exudate and fluids. The study aims to investigate the effect of Negative pressure wound therapy dressings on the rate of wound complications (SSI, WD, seroma) after emergency laparotomy. Patients will be randomised to regular dressings and investigational device 1:1. No other aspect of the care will be changed. Randomisation is planned at the time of skin closure. Patients will be followed-up after 7, 30 and 365 days with two initial visits, surveys and offered a CT scan to investigate incisional hernia formation. The hypothesis is that NPWT dressings decrease the rate of wound complications. The secondary outcome is reduction of SSI, WD, seroma, shorter length of stay, peri-wound blistering, patient satisfaction.
Interventions
DEVICENegative pressure wound therapy
Avance 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.
Mepilex 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.
Sponsors
Uppsala County Council, Sweden
Dalarna County Council, Sweden
Sormland County Council, Sweden
Ostergotland County Council, Sweden
Västmanland County Council, Sweden
Landstingens Ömsesidiga Försäkringsbolag (Löf)
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Assessments and analyses will be masked. It's not feasible to blind Participants and Care Providers
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * Written informed consent * \>10 cm midline incision with primary skin closure * Emergency laparotomy
Exclusion criteria
* 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) * Previous enrolment in the current study * Expected reoperation with 28 days of index laparotomy * Emergency laparotomy within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound complications | 7 and 30 days | Incident rate of wound complications (infection, dehiscence, seroma) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hernias | 5 years | Hernia surgery and diagnoses from the National Patient Registry. |
| Incidence of small bowel obstruction | 5 years | Small bowel obstruction surgery and diagnoses from the National Patient Registry. |
| Incidence of reconstructive surgery | 5 years | Reconstructive abdominal wall surgery from the National Patient Registry. |
| Incidence rate of seromas | 7 and 30 days | Seroma, i.e. collection of fluid in the subcutaneous tissue. |
| Surgical site infections | 7 and 30 days | — |
| Wound dehiscence | 7 and 30 days | Rupture of skin or fascia assessed clinically or with radiology. |
| Length of stay | 30 days | — |
| Quality of life survey | 30 days and 1 year | 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. |
| Scar satisfaction | 30 days and 1 year | Patient and Observer Scar Assessment Scale (POSAS 2.0). Includes pain, vascularity, pigmentation, thickness, relief, pliability and surface area. Lower total score is better. The scale goes from 6-60 for patients and 6-60 for observers. Both also estimate an overall score 1-10 which is not included in the total score when using that aspect of the POSAS. |
| Costs | 30 days | Cost of dressing and health care |
| Mortality | 7, 30 days and 1 year | — |
| Incidence of hematomas | 7 and 30 days | Hematoma, a collection of blood in the subcutaneous tissues. |
| Incidence of ischemia around and in wound | 7 and 30 days | Composite measure of ischemia, necrosisis in wound |
| Incidence of enterocutaneus fistula | 7 and 30 days | Enterocutaneous fistula formation |
| Need for antibiotics after surgery | 7 and 30 days | Incidence rate of antibiotic treatment |
| Incidence of other infections after surgery | 7 and 30 days | Composite measure of other infections (e.g., deep abdominal infections, urinary tract infections, pneumonia) |
| Number of healthcare visits after surgery | 7 and 30 days | Number of healthcare visits |
| Reoperation rate | 7 and 30 days | Any unscheduled surgery after first surgery |
| Incidence of incisional hernias | 1 year | The incidence rate of incisional hernia, the measure is assessed by computer tomography, the need for surgery and clinical diagnosis |
Countries
Sweden
Contacts
Primary ContactErik Osterman, MD PhD
Outcome results
None listed