Skip to content

Pecan Study: Pilot and explorative study comparing the effects of a capillary dressing to negative pressure wound therapy

Pecan Study: Pilot and explorative study comparing the effects of a capillary dressing to negative pressure wound therapy - PECAN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55085
Enrollment
75
Registered
2020-05-19
Start date
2020-08-04
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperatieve wonden (dehiscenties en/of infecties) postoperatively wounds wounds after surgery

Interventions

A capillary dressing (i.e., Vacutex*) will be compared with a commercially available NPWT and standard wound care (defined as dressings providing a moist wound environment which are routinely used i

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * *18 years * Informed consent * having a postoperatively infected wound and/or a wound dehiscence (> 1 cm in depth)

Exclusion criteria

Exclusion criteria: * allergy to one or more of the components of the capillary dressing * exposed vessels * malignant cells in wound * heavily bleeding wounds * if NPWT or Vacutex* is not a treatment option * not familiar with the Dutch language (able to read the informed consent form and to fill in the EQ-5D-5L questionnaire)

Design outcomes

Primary

MeasureTime frame
Feasability outcomes - participants* acceptability of the research plan - recruitment and attrition rates - effect size to facilitate sample size calculations for the definitive study Outcomes of effect: The primary outcome is time to complete wound healing.

Secondary

MeasureTime frame
Secondary outcomes are: * Time to granulation up to level of the skin * Quality of Life (QoL) * Experienced pain (during dressing changes and in between dressing changes) * Experienced itch * Number of adverse and serious adverse events * Direct costs of treatment (i.e. costs of the dressings used, per person)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)