Standard Topical Ointment or Doxepin against pruritus in burn patients

Phase 4

Completed

Conditions: Itch
pruritus
10014982

Registration Number: NL-OMON45341

Lead Sponsor: Vereniging Samenwerkende Brandwondencentra Nederland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 27

Inclusion Criteria

* Age * 18 years
* Healed burns
* Itch with an intensity * 3 as determined by the VAS score for itch at time of the enrolment
* Treatment in one of the three Dutch burn centres
* Total area that itches must not exceed >10% TBSA

Exclusion Criteria

* Unable to give informed consent
* Unable to understand and fill in VAS scores and questionnaires (as determined by the treating burn physician)
* Cutaneous or systemic disease causing itch
* Any diseases or condition that is associated with adverse effects using Doxepin, that is:
o Contra-indications:
* Hypersensitivity to any of its components
o Precautions:
* Glaucoma
* A tendency to urinary retention
* Sever liver disease
* Mania
* Sever heart disease (including cardiac arrhythmias)
* Pregnancy and lactation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in pruritus intensity as measured by the<br /><br>Visual Analogue Scale (VAS), with a decrease of *2 point being defined as<br /><br>clinically significant. If the patient has more than one burn wound area (for<br /><br>example leg and arm) that itches, the area that causes the moist complaints<br /><br>will be designated as the study area. There can only be one study area.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters include the determination of the MIC (Minimal<br /><br>Important Change) of the itch scores, the characteristics and impact of itch as<br /><br>measured by the BIQ (Burn Itch Questionnaire), and scar quality as measured by<br /><br>the POSAS (Patient and Observer Scar Assessment Scale).<br /><br><br /><br>Other study parameters include: the use of hydrating cream, use of escape<br /><br>medication and use of pressure garments. Furthermore, we will register sex,<br /><br>age, medical history, cause of burn, location of burn wound, %TBSA burned, time<br /><br>to wound healing (will be estimated retrospectively), % burn wound area that<br /><br>itches, duration of itch, itch before inclusion and wound treatment<br /><br>(conservative or surgery). </p><br>