The Effect on an Ionic Silver Dressing in Head and Neck Patients With Malignant Fungating Wound (MFW)
Recruitment status was: Recruiting
Background. Malignant fungating wounds(MFW) are caused by cancerous cells invading skin tissue, which exhibit increased bacterial burdens that not only result in a negative physical impact (odour, exudates, pain, and infection) on patients, impairing their quality of life, but they also increase treatment costs. A systematic review of the effectiveness of that the silver-releasing dressing in the management of infected chronic wounds can help enhance control of wound bed infection and inflammation, tissue management, moisture balance, and protect wound edge. However, few studies have examined the effects on people with MFW.
Hypothses In this study that the hypothesized that cancer patients in the ionic silver dressing group will perception higher quality of life compared to patients in the control group who receive non-ionic silver dressing. In addition, we hypothesized that cancer patients who also receive ionic silver dressing will have lower level of symptom distress at end of study compared to patients in the control group receive non-ionic silver dressing care.
Head and Neck Neoplasms
Head and Neck Cancer
Other: silver-releasing dressings
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||The Effect on an Ionic Silver Dressing in Head and Neck Patients With Malignant Fungating Wound|
- The data are collected using questionnaires completed by the subjects themselves.In this study , the primary outcome is health-related quality of life (HRQOL) [ Time Frame: Each group was followed up for two week ] [ Designated as safety issue: No ]
- Also, the Secondary outcome measure using the modified Schulz Malignant Wound Assessment Tool (mSMWAT) [ Time Frame: Each group was followed up for two week ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||November 2009|
|Estimated Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Experimental: silver-releasing dressings
Silver, in its common ionic (active) form (Ag+), is particularly attractive as an antibacterial agent because it can be readily incorporated into dressing materials. Silver-dressing are wound products designed to control infection and provide a wound environment conducive to management exudates, pain, and malodour.
Other: silver-releasing dressings
Experimental group are accepted primary dressing the AQUACEL Ag. control group are provided with the AQUACEL on the wound surface. Wound specialist or primary nurses undertaking wound care are informed by inclusion criteria that the treatment shall be adhered to during the two-week study period.All wounds are cleansed with sterile saline prior to assessment and dressing application.The sterile, non-woven sodium carboxymethylcellulose primary AQUACEL Ag with 1.2% ionic silver.Each secondary dressing is covered a sterile gauze.Dressings are changed between daily assessments when judged necessary.Patients attended the wound ward weekly for treatment evaluation. All participating clinics used the same wound management guidelines and data collection forms.
Other Name: AqCel Ag,AQUACEL,AQUACEL Ag,Aq Cel
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00813631
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Study Chair:||We-Yu Hu||National Taiwan University Hospital|