Wound DehiscenceBALPICNCT07398534
PICO Negative Pressure for Uninfected Foot Ulcers and Wound Dehiscence (BALPIC)
A study testing Professional Wound Care in people with Wound Dehiscence and Wound, run by Ilker Uckay at 1 site in Switzerland.
Trial summary
The investigators compare negative pressure wound therapy (NPWT) using the PICO 7 system versus professional wound debridement alone in adult orthopedic patients with acute, non-infected wound dehiscence or diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Wound Dehiscence, Wound
- What is being tested?
- Professional Wound Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jan 2026to 30 Jun 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
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- 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
Who cannot join
- - 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an Unblinded, Randomized-controlled, Superiority Trial (BALPIC Trial)
The investigators compare negative pressure wound therapy (NPWT) using the PICO 7 system versus professional wound debridement alone in adult orthopedic patients with acute, non-infected wound dehiscence or diabetic foot ulcers. Patients are randomized 1:1 to either PICO therapy (minimum 7 days, up to 42 days) or standard wound care (professional debridement without NPWT). The primary outcome is wound closure without surgical revision at Day 42. The trial is stratified for diabetic foot ulcers to enable subgroup analysis.
Read the detailed description
Acute postoperative wound dehiscence and foot ulcers represent a frequent clinical challenge in adult orthopedic patients worldwide. According to institutional data, wound dehiscence occurs in 2-5% of elective orthopedic procedures, depending on surgery type, patient comorbidities, and obesity. Among patients with diabetes, approximately half will develop foot ulcers during their lifetime.
The management of non-infected wounds can be either surgical (revision surgery with primary closure) or conservative (professional debridement and wound care with or without negative pressure wound therapy). Despite widespread clinical experience with NPWT in orthopedic surgery, high-quality prospective evidence remains scarce. The orthopedic literature lacks adequately powered randomized controlled trials comparing NPWT to standard wound care for acute, non-infected wound dehiscence.
The investigators hypothesize that NPWT leads to superior wound closure rates (85% vs. 70%) and accelerated healing compared to professional debridement alone. The PICO Single Use Negative Pressure Wound Therapy System creates a closed environment over the wound, evacuating exudate into an absorptive dressing while promoting secondary closure through controlled suction at -80 mmHg.
The BALPIC trial evaluates a therapeutic concept rather than comparing different NPWT devices. Infected wounds are excluded, as NPWT is conventionally avoided over purulent wounds to allow free drainage. Wound assessment is performed by specialized wound nurses using standardized measurements and photographic documentation.
- Conditions
- Wound Dehiscence, Wound
- Being tested
- Professional Wound Care
- Keywords
- acute wound, negative pressure vacuum therapy, prospective-randomized trial
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional Wound CareProcedure or surgery
Professional wound debridement by specialized wound nurses, including dressing changes and local antiseptics if clinically indicated, without the use of any negative pressure device. Treatment for up to 42 days based on clinical necessity. Wound assessment weekly.
Individualized professional wound care according to hospital and Swiss nursing guidelines. The intensity of debridement, dressing type, and antiseptic use lies at the discretion of the wound nurse and will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| PICO | Experimental | Application of PICO 7 Single Use NPWT System at -80 mmHg for a minimum of 7 days. PICO therapy may be continued for up to 42 days based on clinical necessity. Device change every 7 days. Wound assessment weekly. SMITH \& NEPHEW MEDICAL LTD. PICO 7 15CM X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP (UDI 04582111156419). The PICO system creates a closed environment over the wound, evacuating exudate into an absorptive dressing while promoting wound closure through controlled suction. Receives: Procedure: Professional Wound Care |
| Professional Wound CAre | Other | Professional wound debridement by specialized wound nurses, including dressing changes and local antiseptics if clinically indicated, without the use of any negative pressure device. Treatment for up to 42 days based on clinical necessity. Wound assessment weekly. Individualized professional wound care according to hospital and Swiss nursing guidelines. The intensity of debridement, dressing type, and antiseptic use lies at the discretion of the wound nurse and will be recorded. Receives: Procedure: Professional Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound closure without surgical revision at Day 42
Wound closure is defined as reduction of wound size by a minimum of 90% compared to baseline, without need for surgical revision. Wound failure is defined as persistent wound (less than 90% reduction) after 42 days or surgical wound revision during the study period.
Measured: Day 42 (±7 days)
Secondary outcomes (6)
2. Rapidity of wound closure
Time to achieve 90% wound size reduction.
Measured: Day 7, 14, 21, 28, 35, and 42
Wound closure without surgical revision at Day 7, 14, 21, 28, and 35
Binary assessment of wound closure at each weekly visit
Measured: Day 7, 14, 21, 28, and 35 (±2 days)
4. Wound closure for diabetic foot ulcers only (stratified analysis)
Pre-specified subgroup analysis for DFU patients.
Measured: Day 42 (±7 days)
5. Adverse events related to wound therapy
All adverse events during the therapy and follow-up time, including device deficiencies in the PICO arm.
Measured: Day 1 to Day 42 (±7 days)
6. Length of hospital stay
Duration of hospital stay in acute care setting.
Measured: Day 1 to Day 42 (±7 days)
7. Overall costs of hospitalization
Total hospitalization costs.
Measured: Day 1 to Day 42 (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start29 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound DehiscenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded, prospective-randomized superiority trial in favor of PICO use
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilker Uckay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ilker Uckay, Balgrist University Hospital
- Investigators
- Ilker Uçkay, Prof. Dr. med., Principal investigator, Balgrist University Hospital, University of Zurich, Zurich, Swizerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398534
- Sponsor's protocol ID
- BASEC 2025-D0043
- Acronym
- BALPIC
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators may share anonymized key elements upon reasonable scientific request to the corresponding persons
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an Unblinded, Randomized-controlled, Superiority Trial (BALPIC Trial)
- ClinicalTrials.gov ID
- NCT07398534
- Acronym / sponsor ID
- BALPIC / BASEC 2025-D0043
- Conditions
- Wound Dehiscence, Wound
- Keywords
- acute wound, negative pressure vacuum therapy, prospective-randomized trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ilker UckayUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 10 Feb 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.
The investigators compare negative pressure wound therapy (NPWT) using the PICO 7 system versus professional wound debridement alone in adult orthopedic patients with acute, non-infected wound dehiscence or diabetic foot ulcers. Patients are randomized 1:1 to either PICO therapy (minimum 7 days, up to 42 days) or standard wound care (professional debridement without NPWT). The primary outcome is wound closure without surgical revision at Day 42. The trial is stratified for diabetic foot ulcers to enable subgroup analysis.
Detailed description
Acute postoperative wound dehiscence and foot ulcers represent a frequent clinical challenge in adult orthopedic patients worldwide. According to institutional data, wound dehiscence occurs in 2-5% of elective orthopedic procedures, depending on surgery type, patient comorbidities, and obesity. Among patients with diabetes, approximately half will develop foot ulcers during their lifetime.
The management of non-infected wounds can be either surgical (revision surgery with primary closure) or conservative (professional debridement and wound care with or without negative pressure wound therapy). Despite widespread clinical experience with NPWT in orthopedic surgery, high-quality prospective evidence remains scarce. The orthopedic literature lacks adequately powered randomized controlled trials comparing NPWT to standard wound care for acute, non-infected wound dehiscence.
The investigators hypothesize that NPWT leads to superior wound closure rates (85% vs. 70%) and accelerated healing compared to professional debridement alone. The PICO Single Use Negative Pressure Wound Therapy System creates a closed environment over the wound, evacuating exudate into an absorptive dressing while promoting secondary closure through controlled suction at -80 mmHg.
The BALPIC trial evaluates a therapeutic concept rather than comparing different NPWT devices. Infected wounds are excluded, as NPWT is conventionally avoided over purulent wounds to allow free drainage. Wound assessment is performed by specialized wound nurses using standardized measurements and photographic documentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded, prospective-randomized superiority trial in favor of PICO use
| Arm | Type | Receives |
|---|---|---|
| PICO | Experimental | Procedure: Professional Wound CareApplication of PICO 7 Single Use NPWT System at -80 mmHg for a minimum of 7 days. PICO therapy may be continued for up to 42 days based on clinical necessity. Device change every 7 days. Wound assessment weekly. SMITH \& NEPHEW MEDICAL LTD. PICO 7 15CM X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP (UDI 04582111156419). The PICO system creates a closed environment over the wound, evacuating exudate into an absorptive dressing while promoting wound closure through controlled suction. |
| Professional Wound CAre | Other | Procedure: Professional Wound CareProfessional wound debridement by specialized wound nurses, including dressing changes and local antiseptics if clinically indicated, without the use of any negative pressure device. Treatment for up to 42 days based on clinical necessity. Wound assessment weekly. Individualized professional wound care according to hospital and Swiss nursing guidelines. The intensity of debridement, dressing type, and antiseptic use lies at the discretion of the wound nurse and will be recorded. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - 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
Key exclusion criteria (9 listed)
- - 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
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 |
|---|---|---|
| Professional Wound CareProfessional wound debridement by specialized wound nurses, including dressing changes and local antiseptics if clinically indicated, without the use of any negative pressure device. Treatment for up to 42 days based on clinical necessity. Wound assessment weekly. Individualized professional wound care according to hospital and Swiss nursing guidelines. The intensity of debridement, dressing type, and antiseptic use lies at the discretion of the wound nurse and will be recorded. | Procedure or surgery | PICO, Professional Wound CAre |
Primary outcome
Wound closure without surgical revision at Day 42
Time frame: Day 42 (±7 days)
Wound closure is defined as reduction of wound size by a minimum of 90% compared to baseline, without need for surgical revision. Wound failure is defined as persistent wound (less than 90% reduction) after 42 days or surgical wound revision during the study period.
6 secondary outcomes
2. Rapidity of wound closure
Time frame: Day 7, 14, 21, 28, 35, and 42
Wound closure without surgical revision at Day 7, 14, 21, 28, and 35
Time frame: Day 7, 14, 21, 28, and 35 (±2 days)
4. Wound closure for diabetic foot ulcers only (stratified analysis)
Time frame: Day 42 (±7 days)
5. Adverse events related to wound therapy
Time frame: Day 1 to Day 42 (±7 days)
6. Length of hospital stay
Time frame: Day 1 to Day 42 (±7 days)
7. Overall costs of hospitalization
Time frame: Day 1 to Day 42 (±7 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 10 Feb 2026.
- Individual participant dataSharing planned: Yes. The investigators may share anonymized key elements upon reasonable scientific request to the corresponding persons
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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. This study is not recruiting at the moment.
Ilker Uçkay, Prof. Dr. med. principal investigator
Balgrist University Hospital, University of Zurich, Zurich, Swizerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professional Wound Care in people with Wound Dehiscence and Wound, run by Ilker Uckay at 1 site in Switzerland.
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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound closure without surgical revision at Day 42 (time frame: Day 42 (±7 days)). 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 10 Feb 2026.