Surgical Wound InfectionCISSINCT06068517
Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery
A study testing Closed incision negative pressure wound therapy and Standard dressing in people with Surgical Wound Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) consists of a non-invasive, vacuum-assisted system that applies negative pressure to… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Closed incision negative pressure wound therapy and Standard dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2026to 31 May 2028
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective or emergency laparotomy, or laparoscopy converted to laparotomy, including surgery for complications after elective operations
- Incision length ≥ 10 cm
- Centers for Disease Control and Prevention (CDC) wound class 1 and 2 (clean, clean-contaminated)
- Abdominal closure with or without mesh implantation
- Primary abdominal closure or closure after open abdomen treatment
- Age over 18 years
- Written informed consent
Who cannot join
- Age ≤ 18 years
- CDC wound class 4 (dirty/infected wound)
- Organ transplantation
- Sensitivity or allergy to silver
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Inselspital, Bern University Hospital
Bern, 3010
Tobias Haltmeier, MD, 31 664 03 04 ext. +41, tobias.haltmeier@insel.ch
About this study
Official title: Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery - A Multicenter Randomized Controlled Trial
Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) consists of a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. It is currently unclear, if ciNPWT reduces SSI in patients undergoing abdominal surgery. This trial will investigate the effect of ciNPWT on SSI in abdominal surgery.
Read the detailed description
Background:
Surgical site infections (SSI) are a frequent complication after abdominal surgery and are associated with increased morbidity and mortality, longer hospital stay, and significantly increased healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) is a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. Recent meta-analyses suggest that ciNPWT reduces the risk of SSI in abdominal surgery. However, based on the available randomized controlled trials (RCT), the evidence for the effect of ciNPWT on SSI in abdominal surgery is insufficient.
Rationale:
Considering the frequent occurrence of SSI in abdominal surgery, associated worse outcomes, and insufficient evidence, an adequately powered, robust RCT investigating the effect of ciNPWT on SSI in elective and emergency abdominal surgery is warranted. Provided that ciNPWT significantly reduces the incidence of SSI, this adjunct to surgical therapy has the potential to fundamentally improve patient outcomes in abdominal surgery.
Aim of the trial:
To investigate the effect of ciNPWT on superficial and deep SSI in patients undergoing elective or emergency abdominal surgery by laparotomy.
Methodology:
Multicenter, open-label, two arm, parallel group RCT. Patients undergoing elective or emergency laparotomy will be enrolled. During surgery, participants will be randomized in a 1:1 ratio to the ciNPWT (treatment) or standard dressing (control) group. After the completion of abdominal surgery and standardized skin closure with staples, either ciNPWT or standard dry dressings will be applied. Other than the study procedure, participants in both groups will be treated the same according to the current standard of care at the participating centers. Data collection will be carried out during the subsequent hospital stay and at 30 (+/- 7) days postoperatively.
Hypothesis:
The investigators hypothesize that ciNPWT will significantly reduce the incidence of superficial and deep SSI in patients undergoing laparotomy.
- Conditions
- Surgical Wound Infection
- Being tested
- Closed incision negative pressure wound therapy, Standard dressing
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed incision negative pressure wound therapyDevice
After the completion of abdominal surgery and standardised skin closure with staples, ciNPWT will be applied, using a commercially available device.
Standard dressingDevice
After the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Closed incision negative pressure wound therapy | Experimental | At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, ciNPWT will be applied, using a commercially available device. The device will be left in place for 7 days. Receives: Device: Closed incision negative pressure wound therapy |
| Standard dressing | Active comparator | At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, conventional dry dressings will be applied. Conventional dressings will be changed according to clinical practice in the participating study centers. Receives: Device: Standard dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite incidence of superficial and deep surgical site infections
Number of participants with a superficial or deep surgical site infections at 30 (+/- 7) days postoperatively.
Measured: 30 (+/- 7) days
Secondary outcomes (10)
Overall surgical site infections (superficial, deep, and organ space)
Number of participants with a superficial or deep or organ space surgical site infections at 30 (+/- 7) days postoperatively.
Measured: 30 (+/- 7) days
Superficial, deep, and organ space surgical site infections as separate outcomes
Number of participants with a superficial surgical site infections at 30 (+/- 7) days postoperatively.
Number of participants with a deep surgical site infections at 30 (+/- 7) days postoperatively.
Number of participants with an organ space surgical site infections at 30 (+/- 7) days postoperatively.
Measured: 30 (+/- 7) days
Other wound complications (wound dehiscence, seroma, hematoma)
Number of participants with another wound complication at 30 (+/- 7) days postoperatively.
Measured: 30 (+/- 7) days
Postoperative hospital length of stay
Measured: Usually between 1 and 14 days
Duration of closed incision negative pressure wound therapy
Measured: 7 days
Number of outpatient visits
Measured: 30 days
Postoperative health-related quality of life (SF-36 Health Survey)
Range from 0 (worst) to 100 (best).
Measured: 30 (+/- 7) days
Costs for inpatient treatment
Measured: Usually between 1 and 14 days
In-hospital mortality
Measured: Usually between 1 and 14 days
30-day mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Mar 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 654 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trials Unit University of Bern
- Responsible party
- Sponsor
- Investigators
- Tobias Haltmeier, MD, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068517
- Sponsor's protocol ID
- CISSI
- Acronym
- CISSI
- Status last verified
- Dec 2024
- First submitted
- 27 Sep 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery - A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06068517
- Acronym / sponsor ID
- CISSI / CISSI
- Conditions
- Surgical Wound Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 654 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Clinical Trials Unit University of Bern
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 5 Oct 2023 (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.
Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) consists of a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. It is currently unclear, if ciNPWT reduces SSI in patients undergoing abdominal surgery. This trial will investigate the effect of ciNPWT on SSI in abdominal surgery.
Detailed description
Background:
Surgical site infections (SSI) are a frequent complication after abdominal surgery and are associated with increased morbidity and mortality, longer hospital stay, and significantly increased healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) is a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. Recent meta-analyses suggest that ciNPWT reduces the risk of SSI in abdominal surgery. However, based on the available randomized controlled trials (RCT), the evidence for the effect of ciNPWT on SSI in abdominal surgery is insufficient.
Rationale:
Considering the frequent occurrence of SSI in abdominal surgery, associated worse outcomes, and insufficient evidence, an adequately powered, robust RCT investigating the effect of ciNPWT on SSI in elective and emergency abdominal surgery is warranted. Provided that ciNPWT significantly reduces the incidence of SSI, this adjunct to surgical therapy has the potential to fundamentally improve patient outcomes in abdominal surgery.
Aim of the trial:
To investigate the effect of ciNPWT on superficial and deep SSI in patients undergoing elective or emergency abdominal surgery by laparotomy.
Methodology:
Multicenter, open-label, two arm, parallel group RCT. Patients undergoing elective or emergency laparotomy will be enrolled. During surgery, participants will be randomized in a 1:1 ratio to the ciNPWT (treatment) or standard dressing (control) group. After the completion of abdominal surgery and standardized skin closure with staples, either ciNPWT or standard dry dressings will be applied. Other than the study procedure, participants in both groups will be treated the same according to the current standard of care at the participating centers. Data collection will be carried out during the subsequent hospital stay and at 30 (+/- 7) days postoperatively.
Hypothesis:
The investigators hypothesize that ciNPWT will significantly reduce the incidence of superficial and deep SSI in patients undergoing laparotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed incision negative pressure wound therapy | Experimental | Device: Closed incision negative pressure wound therapyAt the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, ciNPWT will be applied, using a commercially available device. The device will be left in place for 7 days. |
| Standard dressing | Active comparator | Device: Standard dressingAt the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, conventional dry dressings will be applied. Conventional dressings will be changed according to clinical practice in the participating study centers. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Elective or emergency laparotomy, or laparoscopy converted to laparotomy, including surgery for complications after elective operations
- Incision length ≥ 10 cm
- Centers for Disease Control and Prevention (CDC) wound class 1 and 2 (clean, clean-contaminated)
- Abdominal closure with or without mesh implantation
- Primary abdominal closure or closure after open abdomen treatment
Key exclusion criteria (4 listed)
- Age ≤ 18 years
- CDC wound class 4 (dirty/infected wound)
- Organ transplantation
- Sensitivity or allergy to silver
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 |
|---|---|---|
| Closed incision negative pressure wound therapyAfter the completion of abdominal surgery and standardised skin closure with staples, ciNPWT will be applied, using a commercially available device. | Device | Closed incision negative pressure wound therapy |
| Standard dressingAfter the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied. | Device | Standard dressing |
Primary outcome
Composite incidence of superficial and deep surgical site infections
Time frame: 30 (+/- 7) days
Number of participants with a superficial or deep surgical site infections at 30 (+/- 7) days postoperatively.
10 secondary outcomes
Overall surgical site infections (superficial, deep, and organ space)
Time frame: 30 (+/- 7) days
Superficial, deep, and organ space surgical site infections as separate outcomes
Time frame: 30 (+/- 7) days
Other wound complications (wound dehiscence, seroma, hematoma)
Time frame: 30 (+/- 7) days
Postoperative hospital length of stay
Time frame: Usually between 1 and 14 days
Duration of closed incision negative pressure wound therapy
Time frame: 7 days
Number of outpatient visits
Time frame: 30 days
Postoperative health-related quality of life (SF-36 Health Survey)
Time frame: 30 (+/- 7) days
Costs for inpatient treatment
Time frame: Usually between 1 and 14 days
In-hospital mortality
Time frame: Usually between 1 and 14 days
30-day mortality
Time frame: 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 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Tobias Haltmeier, MD principal investigator
Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed incision negative pressure wound therapy and Standard dressing in people with Surgical Wound Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 Tobias Haltmeier, MD (31 664 03 04 ext. +41, tobias.haltmeier@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of superficial and deep surgical site infections (time frame: 30 (+/- 7) 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 5 Dec 2024.