Management of split-thickness skin graft donor site: An open, prospective, randomized, controlled clinical trial for comparison of three different dressing materials.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00030018

Enrollment

Registered

2022-08-15

Start date

2016-07-25

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Split-skin grafting donor sites

Interventions

Group 1: Biatain® Ibu Biatain® Ibu (Coloplast A/S, Humlebæk, Denmark) is a non-adhesive foam dressing which is made of hydrophilic polyurethane hydrocellular. Biatain Ibu contains incorporated Ibuprof

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: patients scheduled for elective skin grafting were eligible for inclusion in the study

Exclusion criteria

Exclusion criteria: age under 18 years, pregnancy / lactation, local infection at planned split-thickness skin grafting donor site, hypersensitivity to dressing components, malignant or autoimmune disease, vasculitis, connective tissue diseases, immune system disorders, chemo-, radio- and immunosuppressive therapy within 30 days prior to study enrolment, systemic corticosteroids (intake > 10mg/day), drug abuse, excessive alcohol consumption, recent participation in other clinical trials within 4 weeks before study enrolment.

Design outcomes

Primary

Measure	Time frame
1)time-to-healing (days until complete re-epithelialisation daily until the 14th postoperative day) 2Hollander Wound Evaluation Scale (wound assessment following dressing removal using the validated Hollander Wound Evaluation ScaleEvaluation Scale daily until the 14th postoperative day) 3intensity of pain (intensity of pain before, during and after dressing change and at rest/motion using visual analogue scale (0 indicating no pain; 10 indicating unbearable pain) daily until the 14th postoperative day) 4extent of subjective dressing handling (extent of subjective dressing handling (ease of use) after dressing changes using a 4-item daily until the 14th postoperative day)	—

Measure

Time frame

1)time-to-healing (days until complete re-epithelialisation daily until the 14th postoperative day) 2Hollander Wound Evaluation Scale (wound assessment following dressing removal using the validated Hollander Wound Evaluation ScaleEvaluation Scale daily until the 14th postoperative day) 3intensity of pain (intensity of pain before, during and after dressing change and at rest/motion using visual analogue scale (0 indicating no pain; 10 indicating unbearable pain) daily until the 14th postoperative day) 4extent of subjective dressing handling (extent of subjective dressing handling (ease of use) after dressing changes using a 4-item daily until the 14th postoperative day)

—

Secondary

Measure	Time frame
scar quality at 3, 6 and 12 months following split-thickness skin grafting donor site collection.	—

Countries

Austria

Contacts

Public ContactDavid-Benjamin Lumenta

Medizinische Universität Graz, Abteilung für Plastische Ästhetische und Rekonstruktive Chirurgie

david.lumenta@medunigraz.at+4331638581205

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026