An interventional study of closed incision negative pressure wound therapy (ciNPWT) in Surgical Site Infection (SSI), Wound Healing Complication and Seroma, sponsored by University Hospital Hradec Kralove. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University Hospital Hradec Kralove · Not applicable, Interventional, and Supportive care
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:
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 30 is below the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →University Hospital Hradec Kralove is the lead sponsor of 49 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Identification as "high-risk" for wound healing complications based on a clinical risk screening at admission.
Signed .
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.
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.
Device: 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
Feasibility of targeted prophylactic ciNPWT
Feasibility of prophylactic ciNPWT described as: Recruitment rate (%)
Time frame: Up to 30 postoperative days
Feasibility of targeted prophylactic ciNPWT
Feasibility of prophylactic ciNPWT described as: Completion rate (%)
Time frame: Up to 30 postoperative days
Feasibility of targeted prophylactic ciNPWT
Feasibility of prophylactic ciNPWT described as: Safety and technical complications (description)
Time frame: Up to 30 postoperative days
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).
Time frame: 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.
Time frame: 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).
Time frame: Up to 30 postoperative days
Subjective treatment satisfaction
Treatment satisfaction and patient experience via an original questionnaire (scale 8-40, higher number = worse outcome).
Time frame: Up to 30 postoperative days
No study locations are listed for this record.
Start is estimated for Jul 2026; primary completion for Jun 2028, 23 months later.
Of 201 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 23 months is close to that.
Counting every sponsor, half of 208 studies reached it within 24 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Hradec Kralove