Surgical IncisionTELINNCT07003906
Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy
A study testing Negative pressure wound therapy and Standard postoperative dressing in people with Surgical Incision and Wound Dehiscence, run by Uppsala University at 6 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Incision, Wound Dehiscence, Surgical Site Infection
- What is being tested?
- Negative pressure wound therapy and Standard postoperative dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 6 sitesSweden
- Study dates
- 16 Dec 2025to Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Written informed consent
- >10 cm midline incision with primary skin closure
- Emergency laparotomy
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Not yet recruiting
Mälar Hospital
Eskilstuna
Carl-Johan Drott, MD PhD
Ninos Oussi, MD PhD
- Recruiting
Linköping University Hospital
Linköping
Marcus Permert Fraser, MD
- Recruiting
Mora Hospital
Mora
Johanna Österberg, MD PhD
- Recruiting
Vrinnevi Hospital
Norrköping
Måns Muhrbeck, MD PhD
- Recruiting
Uppsala University Hospital
Uppsala, 75185
Erik Osterman, MD PhD
Fredrik Linder, MD PhD
- Recruiting
Västmanlands Hospital Västerås
Västerås
Maziar Nikberg, MD, PhD
About this study
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.
Read the 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 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.
- Conditions
- Surgical Incision, Wound Dehiscence, Surgical Site Infection, Incisional Hernia, Quality of Life
- Being tested
- Negative pressure wound therapy, Standard postoperative dressing
- Keywords
- emergency surgery, negative pressure wound therapy, randomised controlled trial
- Medical subject headings
- Surgical Wound, Surgical Wound Infection, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapyDevice
Also called Avance Solo
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.
Standard postoperative dressingDevice
Also called Mepilex Border Post-Op
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device | Experimental | Will recieve 7 days of treatment with negative pressure wound therapy after closure of emergency surgery incision Receives: Device: Negative pressure wound therapy |
| Standard of care | Active comparator | Will recieve a regular dressing after closure of emergency surgery incision Receives: Device: Standard postoperative dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound complications
Incident rate of wound complications (infection, dehiscence, seroma)
Measured: 14 and 30 days
Secondary outcomes (19)
Surgical site infections
Measured: 14 and 30 days
Wound dehiscence
Rupture of skin or fascia assessed clinically or with radiology.
Measured: 14 and 30 days
Length of stay
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 year
Mortality
Measured: 14, 30 days and 1 year
Costs
Cost of dressing and health care
Measured: 30 days
Incidence of hernias
Hernia surgery and diagnoses from the National Patient Registry.
Measured: 5 years
Incidence of small bowel obstruction
Small bowel obstruction surgery and diagnoses from the National Patient Registry.
Measured: 5 years
Incidence of reconstructive surgery
Reconstructive abdominal wall surgery from the National Patient Registry.
Measured: 5 years
Incidence rate of seromas
Seroma, i.e. collection of fluid in the subcutaneous tissue.
Measured: 14 and 30 days
Incidence of hematomas
Hematoma, a collection of blood in the subcutaneous tissues.
Measured: 14 and 30 days
Incidence of ischemia around and in wound
Composite measure of ischemia, necrosisis in wound
Measured: 14 and 30 days
Incidence of enterocutaneus fistula
Enterocutaneous fistula formation
Measured: 14 and 30 days
Need for antibiotics after surgery
Incidence rate of antibiotic treatment
Measured: 14 and 30 days
Incidence of other infections after surgery
Composite measure of other infections (e.g., deep abdominal infections, urinary tract infections, pneumonia)
Measured: 14 and 30 days
Number of healthcare visits after surgery
Number of healthcare visits
Measured: 14 and 30 days
Reoperation rate
Any unscheduled surgery after first surgery
Measured: 14 and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start16 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala County Council, Sweden, Dalarna County Council, Sweden, Sormland County Council, Sweden, Ostergotland County Council, Sweden, Västmanland County Council, Sweden, Landstingens Ömsesidiga Försäkringsbolag (Löf)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003906
- Sponsor's protocol ID
- TELIN-1337
- Other IDs
- CIV-24-11-049998, FOU2025-00096
- Acronym
- TELIN
- Status last verified
- Jul 2026
- First submitted
- 14 May 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data with complete removal of identifying information is planned to be available on request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy
- ClinicalTrials.gov ID
- NCT07003906
- Acronym / sponsor ID
- TELIN / TELIN-1337
- Conditions
- Surgical Incision, Wound Dehiscence, Surgical Site Infection, Incisional Hernia, Quality of Life
- Keywords
- emergency surgery, negative pressure wound therapy, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala County Council, Sweden, Dalarna County Council, Sweden, Sormland County Council, Sweden, Ostergotland County Council, Sweden, Västmanland County Council, Sweden, Landstingens Ömsesidiga Försäkringsbolag (Löf)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational device | Experimental | Device: Negative pressure wound therapyWill recieve 7 days of treatment with negative pressure wound therapy after closure of emergency surgery incision |
| Standard of care | Active comparator | Device: Standard postoperative dressingWill recieve a regular dressing after closure of emergency surgery incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- Written informed consent
- >10 cm midline incision with primary skin closure
- Emergency laparotomy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure wound therapyAlso: Avance SoloAvance 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. | Device | Investigational device |
| Standard postoperative dressingAlso: Mepilex Border Post-OpMepilex 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. | Device | Standard of care |
Primary outcome
Wound complications
Time frame: 14 and 30 days
Incident rate of wound complications (infection, dehiscence, seroma)
19 secondary outcomes
Surgical site infections
Time frame: 14 and 30 days
Wound dehiscence
Time frame: 14 and 30 days
Length of stay
Time frame: 30 days
Quality of life survey
Time frame: 30 days and 1 year
Scar satisfaction
Time frame: 30 days and 1 year
Incidence of incisional hernias
Time frame: 1 year
Mortality
Time frame: 14, 30 days and 1 year
Costs
Time frame: 30 days
Incidence of hernias
Time frame: 5 years
Incidence of small bowel obstruction
Time frame: 5 years
Incidence of reconstructive surgery
Time frame: 5 years
Incidence rate of seromas
Time frame: 14 and 30 days
Incidence of hematomas
Time frame: 14 and 30 days
Incidence of ischemia around and in wound
Time frame: 14 and 30 days
Incidence of enterocutaneus fistula
Time frame: 14 and 30 days
Need for antibiotics after surgery
Time frame: 14 and 30 days
Incidence of other infections after surgery
Time frame: 14 and 30 days
Number of healthcare visits after surgery
Time frame: 14 and 30 days
Reoperation rate
Time frame: 14 and 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided. Anonymised data with complete removal of identifying information is planned to be available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure wound therapy and Standard postoperative dressing in people with Surgical Incision and Wound Dehiscence, run by Uppsala University at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik Osterman, MD PhD (+460186110000, erik.osterman@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound complications (time frame: 14 and 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.