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Scar quality after tangential excision of burns


- candidate number26523
- NTR NumberNTR6232
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jan-2017
- Secondary IDsMETC 2016-66 NL58875.101.16 ABR
- Public TitleScar quality after tangential excision of burns
- Scientific TitleA multicenter randomized controlled trial comparing long term scar quality after hydrosurgical versus conventional tangential excision of deep dermal burns
- ACRONYMHyCon
- hypothesisThe aim of this study is to assess long term scar quality of deep dermal burns after debridement with hydrosurgical excision versus conventional tangential excision.
- Healt Condition(s) or Problem(s) studiedBurns
- Inclusion criteriaDeep dermal burns that require excision and grafting
- Exclusion criteria- Burn wound < 50cm2
- TBSA > 30%
- Full thickness burns
- Chemical or electrical burns
- Infected wounds
- Patients that are unlikely to comply with requirement of the study protocol and follow-up
- No informed consent
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-jan-2017
- planned closingdate31-dec-2019
- Target number of participants137
- InterventionsHydrosurgery
- Primary outcomeScar quality 12 months post-surgery assessed by the observer score of the POSAS scale will be tested for normality before univariate analyses will be performed.
- Secondary outcome- To demonstrate increased dermal preservation in deep dermal burns after debridement with hydrosurgically versus conventional excision.

- To determine the minimal clinical important (MIC) change of the Patient and Observer Scar Assessment Scale (POSAS).
- Timepoints- 3 months post surgery
- 6 months post surgery
- 12 months post surgery
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES C.H. van der Vlies
- CONTACT for SCIENTIFIC QUERIES C.M. Legemate
- Sponsor/Initiator Vereniging Samenwerkende Brandwondencentra Nederland
- Funding
(Source(s) of Monetary or Material Support)
Dutch Burns Foundation (Nederlandse Brandwonden Stichting)
- Publications
- Brief summaryBurn eschar is conventionally removed by tangential excision with a knife. This procedure is not only associated with substantial blood loss but also with unnecessary removal of viable dermis. During the last decade hydrosurgery has become popular in burn surgery. Hydrosurgery is generally thought to be a more precise and controlled manner of burn debridement leading to preservation of more dermal viable tissue and possibly to better scar quality. The objective of this study is to compare scar quality after conventional tangential excision versus hydrosurgical excision in patients with deep dermal burn wounds.
- Main changes (audit trail)
- RECORD23-jan-2017 - 12-apr-2017


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