Surgical Site Infection (SSI)NCT07645547
Prophylactic Use of ciNPWT in Gynecologic Laparotomy
A study testing closed incision negative pressure wound therapy (ciNPWT) in people with Surgical Site Infection (SSI) and Wound Healing Complication, run by University Hospital Hradec Kralove.
Trial summary
This is a prospective, open-label, non-randomized interventional feasibility study with a nested qualitative analysis. The study exploratively verifies the feasibility of targeted prophylactic closed incision negative pressure wound therapy (ciNPWT) in clinical practice for patients with a high predicted risk of wound… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Site Infection (SSI), Wound Healing Complication, Seroma
- What is being tested?
- closed incision negative pressure wound therapy (ciNPWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients scheduled for planned abdominal surgery for gynecologic or gynecologic-oncologic indications.
- Identification as "high-risk" for wound healing complications based on a clinical risk screening at admission.
- Signed informed consent.
Who cannot join
- Failure to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of Prophylactic Negative Pressure Wound Therapy (ciNPWT) in High-Risk Patients in Gynecologic Oncology: A Prospective Feasibility Study and Nested Qualitative Analysis
This is a prospective, open-label, non-randomized interventional feasibility study with a nested qualitative analysis. The study exploratively verifies the feasibility of targeted prophylactic closed incision negative pressure wound therapy (ciNPWT) in clinical practice for patients with a high predicted risk of wound healing complications and compares the 30-day incidence of postoperative complications with standard dressing.
Participants will:
- Get ciNPWT or standard dressing after planned laparotomy
- Answer the questionairs about qualite of life
- Will visit the clinic 30 days after surgery to see the final result
- Being tested
- closed incision negative pressure wound therapy (ciNPWT)
- Keywords
- ciNPWT, laparotomy, surgical site infection, SSI, feasibility, PROMs, ASEPSIS
- Medical subject headings
- Surgical Wound Infection, Seroma, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed incision negative pressure wound therapy (ciNPWT)Device
targeted prophylactic closed incision negative pressure wound therapy in clinical practice for patients with a high predicted risk of wound healing complications
| Study group | Role | What they receive |
|---|---|---|
| Preventive ciNPWT | Experimental | Not described Receives: Device: closed incision negative pressure wound therapy (ciNPWT) |
| Standard dressing | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of targeted prophylactic ciNPWT
Feasibility of prophylactic ciNPWT described as: Recruitment rate (%)
Measured: Up to 30 postoperative days
Feasibility of targeted prophylactic ciNPWT
Feasibility of prophylactic ciNPWT described as: Completion rate (%)
Measured: Up to 30 postoperative days
Feasibility of targeted prophylactic ciNPWT
Feasibility of prophylactic ciNPWT described as: Safety and technical complications (description)
Measured: Up to 30 postoperative days
Secondary outcomes (4)
Objective assessment of wound healing
Objective assessment of wound healing using the ASEPSIS (Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay = ASEPSIS) scoring system (scale 0-100, higher number = worse outcome).
Measured: Up to 30 postoperative days.
Subjective assessment of pain
Pain assessment using the Numeric Rating Scale (NRS, scale 0-10, higher number = worse outcome) at rest and during movement.
Measured: Up to 30 postoperative days
Subjective assessment of quality of life
Patient-Reported Outcomes including the 5-level version of Quality of life EuroQol Group questionnaire (EQ-5D-5L, scale 5-25, higher number = worse outcome).
Measured: Up to 30 postoperative days
Subjective treatment satisfaction
Treatment satisfaction and patient experience via an original questionnaire (scale 8-40, higher number = worse outcome).
Measured: Up to 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection (SSI)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645547
- Sponsor's protocol ID
- 202511 P02
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Prophylactic Negative Pressure Wound Therapy (ciNPWT) in High-Risk Patients in Gynecologic Oncology: A Prospective Feasibility Study and Nested Qualitative Analysis
- ClinicalTrials.gov ID
- NCT07645547
- Acronym / sponsor ID
- 202511 P02
- Keywords
- ciNPWT, laparotomy, surgical site infection, SSI, feasibility, PROMs, ASEPSIS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Jun 2026 (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.
This is a prospective, open-label, non-randomized interventional feasibility study with a nested qualitative analysis. The study exploratively verifies the feasibility of targeted prophylactic closed incision negative pressure wound therapy (ciNPWT) in clinical practice for patients with a high predicted risk of wound healing complications and compares the 30-day incidence of postoperative complications with standard dressing.
Participants will:
- Get ciNPWT or standard dressing after planned laparotomy
- Answer the questionairs about qualite of life
- Will visit the clinic 30 days after surgery to see the final result
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventive ciNPWT | Experimental | Device: closed incision negative pressure wound therapy (ciNPWT) |
| Standard dressing | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult female patients scheduled for planned abdominal surgery for gynecologic or gynecologic-oncologic indications.
- Identification as "high-risk" for wound healing complications based on a clinical risk screening at admission.
- Signed informed consent.
Key exclusion criteria (1 listed)
- Failure to provide informed consent.
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 therapy (ciNPWT)targeted prophylactic closed incision negative pressure wound therapy in clinical practice for patients with a high predicted risk of wound healing complications | Device | Preventive ciNPWT |
Primary outcome
Feasibility of targeted prophylactic ciNPWT
Time frame: Up to 30 postoperative days
Feasibility of prophylactic ciNPWT described as: Recruitment rate (%)
Feasibility of targeted prophylactic ciNPWT
Time frame: Up to 30 postoperative days
Feasibility of prophylactic ciNPWT described as: Completion rate (%)
Feasibility of targeted prophylactic ciNPWT
Time frame: Up to 30 postoperative days
Feasibility of prophylactic ciNPWT described as: Safety and technical complications (description)
4 secondary outcomes
Objective assessment of wound healing
Time frame: Up to 30 postoperative days.
Subjective assessment of pain
Time frame: Up to 30 postoperative days
Subjective assessment of quality of life
Time frame: Up to 30 postoperative days
Subjective treatment satisfaction
Time frame: Up to 30 postoperative 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 12 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing closed incision negative pressure wound therapy (ciNPWT) in people with Surgical Site Infection (SSI) and Wound Healing Complication, run by University Hospital Hradec Kralove.
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 3 inclusion and 1 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Klara Balcarova (+420731964956, klara.balcarova@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of targeted prophylactic ciNPWT (time frame: Up to 30 postoperative days). The study lists 3 primary outcomes in all. 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 12 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.