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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-24-11-049998 | Other Identifier | Swedish Medical Products Agency | |
| FOU2025-00096 | Other Identifier | Uppsala County |
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| Name | Class |
|---|---|
| Uppsala County Council, Sweden | OTHER_GOV |
| Dalarna County Council, Sweden | OTHER |
| Sormland County Council, Sweden | OTHER |
| Ostergotland County Council, Sweden |
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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.
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 14, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device | Experimental | Will recieve 7 days of treatment with negative pressure wound therapy after closure of emergency surgery incision |
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| Standard of care | Active Comparator | Will recieve a regular dressing after closure of emergency surgery incision |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative pressure wound therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound complications | Incident rate of wound complications (infection, dehiscence, seroma) | 14 and 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infections | 14 and 30 days | |
| Wound dehiscence | Rupture of skin or fascia assessed clinically or with radiology. | 14 and 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erik Osterman, MD PhD | Contact | +460186110000 | erik.osterman@akademiska.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mälar Hospital | Not yet recruiting | Eskilstuna | Sweden |
Anonymised data with complete removal of identifying information is planned to be available on request.
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| OTHER |
| Västmanland County Council, Sweden | OTHER_GOV |
| Landstingens Ömsesidiga Försäkringsbolag (Löf) | UNKNOWN |
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Assessments and analyses will be masked. It's not feasible to blind Participants and Care Providers
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| Standard postoperative dressing | Device | 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. |
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| Length of stay | 30 days |
| 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. | 30 days and 1 year |
| Scar satisfaction | 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. | 30 days and 1 year |
| Incidence of incisional hernias | The incidence rate of incisional hernia, the measure is assessed by computer tomography, the need for surgery and clinical diagnosis | 1 year |
| Mortality | 14, 30 days and 1 year |
| Costs | Cost of dressing and health care | 30 days |
| Incidence of hernias | Hernia surgery and diagnoses from the National Patient Registry. | 5 years |
| Incidence of small bowel obstruction | Small bowel obstruction surgery and diagnoses from the National Patient Registry. | 5 years |
| Incidence of reconstructive surgery | Reconstructive abdominal wall surgery from the National Patient Registry. | 5 years |
| Incidence rate of seromas | Seroma, i.e. collection of fluid in the subcutaneous tissue. | 14 and 30 days |
| Incidence of hematomas | Hematoma, a collection of blood in the subcutaneous tissues. | 14 and 30 days |
| Incidence of ischemia around and in wound | Composite measure of ischemia, necrosisis in wound | 14 and 30 days |
| Incidence of enterocutaneus fistula | Enterocutaneous fistula formation | 14 and 30 days |
| Need for antibiotics after surgery | Incidence rate of antibiotic treatment | 14 and 30 days |
| Incidence of other infections after surgery | Composite measure of other infections (e.g., deep abdominal infections, urinary tract infections, pneumonia) | 14 and 30 days |
| Number of healthcare visits after surgery | Number of healthcare visits | 14 and 30 days |
| Reoperation rate | Any unscheduled surgery after first surgery | 14 and 30 days |
| Linköping University Hospital | Recruiting | Linköping | Sweden |
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| Mora Hospital | Recruiting | Mora | Sweden |
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| Vrinnevi Hospital | Recruiting | Norrköping | Sweden |
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| Uppsala University Hospital | Recruiting | Uppsala | 75185 | Sweden |
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| Västmanlands Hospital Västerås | Recruiting | Västerås | Sweden |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D013530 | Surgical Wound Infection |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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