Negative Pressure Wound Therapy System Compared to Repeated Wound Care for Open Postoperative Wound Problems and Other Foot Wounds (BALPIC Study)
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
- 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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Prof. Dr. med. Ilker Uçkay
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Ilker Uçkay
+41 44 386 11 11
info@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
Informations générales
Balgrist University Hospital, University of Zurich, Zurich, Swizerland
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
20.01.2026
(BASEC)
Identifiant de l'essai ICTRP
NCT07398534 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an unblinded, randomized-controlled, superiority trial (BALPIC Trial) (BASEC)
Titre académique
PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an Unblinded, Randomized-controlled, Superiority Trial (BALPIC Trial) (ICTRP)
Titre public
PICO Negative Pressure for Uninfected Foot Ulcers and Wound Dehiscence (BALPIC) (ICTRP)
Maladie en cours d'investigation
Wound DehiscenceWound (ICTRP)
Intervention étudiée
Procedure: Professional Wound Care (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Ilker Ukay, Prof. Dr. med., Balgrist University Hospital, University of Zurich, Zurich, Swizerland (ICTRP)
ID secondaires
BASEC 2025-D0043 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT07398534 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
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