Clinical trial NCT02904200: Clinical Investigation of Two Different Wound Dressings
Official title: A Randomized Open, Controlled Pilot Investigation Comparing Trauma to the Periwound Skin and Pain During Treatment With Avance NPWT System When Using Two Different Fixations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wounds and Injuries
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings

The secondary objectives are to evaluate pain before, during, and after dressing removal from baseline to termination

Detailed description: A prospective randomized clinical investigation will be conducted at two sites in Sweden.

Male or female, 18 years or older with following wound types:

* traumatic, surgical or dehisced wounds,
* venous leg ulcer or pressure ulcer will be included into the clinical investigation.

  32 evaluated subjects (i:e 16 subjects per arm) will be followed during maximum three weeks. The treatment arm (either silicon adhesive dressing or acrylic adhesive dressing). Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of skin (normal/dry/flaky/oily/moist) and age. Eligible patients will be randomized to receive either silicon adhesive dressing or acrylic adhesive dressing in a ratio of 1:1 provided.

Eligibility criteria: Inclusion Criteria:

1. Traumatic, surgical or dehisced wounds, Venous Leg Ulcer, Diabetic Foot Ulcer or Pressure Ulcer indicated for treatment with NPWT therapy
2. In case of multiple wounds the target wound must be ≥10 cm distant from other wounds. Selection of the target wound is according to the investigator's preference.
3. Peri-wound skin assessable and 5 cm of peri-wound skin present around the wound
4. Male or female, 18 years of age and above
5. Signed Informed Consent

Exclusion Criteria:

1. Dressing sizes does not fit the target wound
2. Unexplored blind tunnels or non-enteric fistula
3. Untreated osteomyelitis
4. Malignant wounds
5. Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent.
6. Wounds with necrotic tissue or eschar (if not adequately debrided)
7. Significantly bleeding wounds, as judged by the investigator
8. Subject not suitable for the investigation according to the investigator's judgment
9. Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
10. Known allergy/hypersensitivity to any of the components included into the investigation.

Primary outcomes:
measure: Changes on Peri-Wound Skin
timeFrame: Visit 4 last visit (day 12)
Secondary outcomes:
measure: VAS Scale (0-100mm)
timeFrame: 0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)
Other outcomes:
Locations:
city: Sundsvall
country: Sweden
facility: Sundsvalls sjukhus
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
Study officials:
affiliation: Sundsvalls Sjukhus
name: Marianne Bergstrom
role: PRINCIPAL_INVESTIGATOR
References: