Negative Pressure Wound Therapy System Compared to Repeated Wound Care for Open Postoperative Wound Problems and Other Foot Wounds (BALPIC Study)
Zusammenfassung der Studie
Acute postoperative wound complications and generally difficult-to-heal wounds—especially in patients with multiple comorbidities—are common in orthopedic departments. In addition to professional wound treatment, there are other treatment options. One of these is known as negative pressure therapy. This involves suctioning wound fluid, which theoretically can lead to faster healing than conventional wound care alone. Earlier devices of this kind are called 'Vacuum-Assisted Closure Systems' (VAC). A further development for outpatient use is the smaller, portable PICO devices, which are also available in Switzerland. A PICO device consists of a small pump that generates continuous negative pressure for up to seven days. Despite the availability of these devices, surprisingly little is known about the specific advantages that PICO offers compared to professional wound care in the daily routine of orthopedic hospitals. Particularly, direct comparative studies are lacking. With this prospective randomized study, we aim to investigate whether negative pressure therapy with PICO or sole professional wound care leads to faster or better wound healing or whether both methods are equivalent. The treatment will be carried out by experienced wound care specialists, supported by orthopedic surgeons and infectious disease specialists. Patients with open postoperative wounds or other open foot wounds can participate. Allocation to treatment is random: either the wound is treated with PICO or exclusively through professional wound care. The study lasts a total of 6 weeks. During this time, either a weekly PICO change or weekly wound care will occur, until complete wound closure. After 6 weeks, a final assessment will take place.
(BASEC)
Untersuchte Intervention
In the PICO group, the PICO-7 device is applied continuously for 7 days and can, if necessary, be applied for an additional 7 days. The application can take place both inpatient and outpatient.
In the non-PICO group, treatment is provided through repeated professional wound care, the frequency of which is determined individually and typically corresponds to about one active wound care session per week.
Treatment in both groups is monitored by the wound care team and the treating physicians.
(BASEC)
Untersuchte Krankheit(en)
Wound Problems
(BASEC)
- Presence of an acute, open, and clinically non-infected wound that requires additional measures - First treatment episode of the current wound (no prior treatments of the same wound in the last 12 months) - Wound measures ≥ 0.5 cm in width, length, or depth (BASEC)
Ausschlusskriterien
- Previous treatment with a vacuum-assisted wound therapy system within the last 12 months—regardless of treatment success, the treating hospital, or the location of the previous wound - Visible, active bleeding from the wound - Wound size of >10 cm in any dimension (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Prof. Dr. med. Ilker Uçkay
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Ilker Uçkay
+41 44 386 11 11
info@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
Allgemeine Auskünfte
Balgrist University Hospital, University of Zurich, Zurich, Swizerland
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
20.01.2026
(BASEC)
ICTRP Studien-ID
NCT07398534 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an unblinded, randomized-controlled, superiority trial (BALPIC Trial) (BASEC)
Wissenschaftlicher Titel
PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an Unblinded, Randomized-controlled, Superiority Trial (BALPIC Trial) (ICTRP)
Öffentlicher Titel
PICO Negative Pressure for Uninfected Foot Ulcers and Wound Dehiscence (BALPIC) (ICTRP)
Untersuchte Krankheit(en)
Wound DehiscenceWound (ICTRP)
Untersuchte Intervention
Procedure: Professional Wound Care (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- - Age = 18 years
- Able to consent
- Patient of orthopaedic surgery or of the (Diabetic) Foot Polyclinic at the Balgrist
University Hospital
- Presence of an acute, dehiscent, clinically uninfected wound requiring additional
measures
- First episode of wound treatment for the actual wound (no recurrences) in the last
12 months
- Wound measuring = 0.5 cm in wide, length or depth
- 42 days of scheduled follow-up
- Bacterial orthopaedic infections of any nature, independently of implants or
co-morbidities according to clinical, laboratory, radiological, microbiological
features of infection
- First or second episode of infection
Exclusion Criteria:
- - Patient's individual refusal to participate
- Patient already treated with any vacuum-assisted wound device for any wound in the
last 12 months independently of therapy success, the hospital or the localization
of the prior wound
- Underlying liquor leak (spine surgery)
- Visually active bleeding from the wound
- Wound size >10 cm in any dimension
- Anticipated active clinical follow-up of less than 42 days
- Other wound treatments besides PICO and debridement (e.g. hyperbaric oxygen therapy,
other negative-pressure devices, local antibiotics, local antibiotic dressings)
(however, local antiseptics and dressing changes remain allowed)
- Immediate surgical wound revision in the operating theatre for closure
- Planned plastic or reconstructive surgery already at inclusion (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Wound closure without surgical revision at Day 42 (ICTRP)
2. Rapidity of wound closure;Wound closure without surgical revision at Day 7, 14, 21, 28, and 35;4. Wound closure for diabetic foot ulcers only (stratified analysis);5. Adverse events related to wound therapy;6. Length of hospital stay;7. Overall costs of hospitalization (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Ilker Ukay, Prof. Dr. med., Balgrist University Hospital, University of Zurich, Zurich, Swizerland (ICTRP)
Sekundäre IDs
BASEC 2025-D0043 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT07398534 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar