NCT Number: NCT07003906
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Mälar Hospital, Eskilstuna, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: Mepilex Border Post-Op
Time frame: 14 and 30 days
Incident rate of wound complications (infection, dehiscence, seroma)
Time frame: 14 and 30 days
Time frame: 14 and 30 days
Rupture of skin or fascia assessed clinically or with radiology.
Time frame: 30 days
Time frame: 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.
Time frame: 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.
Time frame: 1 year
The incidence rate of incisional hernia, the measure is assessed by computer tomography, the need for surgery and clinical diagnosis
Time frame: 14, 30 days and 1 year
Time frame: 30 days
Cost of dressing and health care
Time frame: 5 years
Hernia surgery and diagnoses from the National Patient Registry.
Time frame: 5 years
Small bowel obstruction surgery and diagnoses from the National Patient Registry.
Time frame: 5 years
Reconstructive abdominal wall surgery from the National Patient Registry.
Time frame: 14 and 30 days
Seroma, i.e. collection of fluid in the subcutaneous tissue.
Time frame: 14 and 30 days
Hematoma, a collection of blood in the subcutaneous tissues.
Time frame: 14 and 30 days
Composite measure of ischemia, necrosisis in wound
Time frame: 14 and 30 days
Enterocutaneous fistula formation
Time frame: 14 and 30 days
Incidence rate of antibiotic treatment
Time frame: 14 and 30 days
Composite measure of other infections (e.g., deep abdominal infections, urinary tract infections, pneumonia)
Time frame: 14 and 30 days
Number of healthcare visits
Time frame: 14 and 30 days
Any unscheduled surgery after first surgery
Contact information is provided by the study sponsor or research team.
Uppsala University
Other
Acronym: TELIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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