Prophylactic Use of ciNPWT in Gynecologic Laparotomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital Hradec Kralove
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult female patients scheduled for planned abdominal surgery for gynecologic or gynecologic-oncologic indications.
Disqualifiers
Failure to provide informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
closed incision negative pressure wound therapy (ciNPWT)
Devicetargeted prophylactic closed incision negative pressure wound therapy in clinical practice for patients with a high predicted risk of wound healing complications
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Preventive ciNPWTExperimental treatment 1 intervention
Group B: Standard dressingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility of targeted prophylactic ciNPWT
Feasibility of prophylactic ciNPWT described as: Recruitment rate (%)
Time frame
Up to 30 postoperative days2
Feasibility of targeted prophylactic ciNPWT
Feasibility of prophylactic ciNPWT described as: Completion rate (%)
Time frame
Up to 30 postoperative days3
Feasibility of targeted prophylactic ciNPWT
Feasibility of prophylactic ciNPWT described as: Safety and technical complications (description)
Time frame
Up to 30 postoperative daysSecondary outcomes
1
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.2
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 days3
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 days4
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 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: