An interventional study of Negative pressure wound therapy and Standard postoperative dressing in Surgical Incision, Wound Dehiscence and Surgical Site Infection, sponsored by Uppsala University. Recruiting at 6 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Uppsala University · Not applicable, Interventional, and Prevention
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's planned enrollment of 720 is above the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will recieve 7 days of treatment with negative pressure wound therapy after closure of emergency surgery incision
Device: Negative pressure wound therapy
Will recieve a regular dressing after closure of emergency surgery incision
Device: Standard postoperative dressing
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.
Also known as: Avance Solo
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.
Also known as: Mepilex Border Post-Op
Wound complications
Incident rate of wound complications (infection, dehiscence, seroma)
Time frame: 14 and 30 days
Surgical site infections
Time frame: 14 and 30 days
Wound dehiscence
Rupture of skin or fascia assessed clinically or with radiology.
Time frame: 14 and 30 days
Length of stay
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 1 year
Mortality
Time frame: 14, 30 days and 1 year
Costs
Cost of dressing and health care
Time frame: 30 days
Incidence of hernias
Hernia surgery and diagnoses from the National Patient Registry.
Time frame: 5 years
Incidence of small bowel obstruction
Small bowel obstruction surgery and diagnoses from the National Patient Registry.
Time frame: 5 years
Incidence of reconstructive surgery
Reconstructive abdominal wall surgery from the National Patient Registry.
Time frame: 5 years
Incidence rate of seromas
Seroma, i.e. collection of fluid in the subcutaneous tissue.
Time frame: 14 and 30 days
Incidence of hematomas
Hematoma, a collection of blood in the subcutaneous tissues.
Time frame: 14 and 30 days
Incidence of ischemia around and in wound
Composite measure of ischemia, necrosisis in wound
Time frame: 14 and 30 days
Incidence of enterocutaneus fistula
Enterocutaneous fistula formation
Time frame: 14 and 30 days
Need for antibiotics after surgery
Incidence rate of antibiotic treatment
Time frame: 14 and 30 days
Incidence of other infections after surgery
Composite measure of other infections (e.g., deep abdominal infections, urinary tract infections, pneumonia)
Time frame: 14 and 30 days
Number of healthcare visits after surgery
Number of healthcare visits
Time frame: 14 and 30 days
Reoperation rate
Any unscheduled surgery after first surgery
Time frame: 14 and 30 days
Plan to share: Undecided — Anonymised data with complete removal of identifying information is planned to be available on request.
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