The Effect on an Ionic Silver Dressing in Head and Neck Patients With Malignant Fungating Wound (MFW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813631
Recruitment Status : Unknown
Verified March 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 23, 2008
Last Update Posted : May 19, 2009
Information provided by:
National Taiwan University Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Head and Neck Cancer Wounds Ulcer Other: silver-releasing dressings Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect on an Ionic Silver Dressing in Head and Neck Patients With Malignant Fungating Wound
Study Start Date : January 2009
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Also, the Secondary outcome measure using the modified Schulz Malignant Wound Assessment Tool (mSMWAT) [ Time Frame: Each group was followed up for two week ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • (1.)Had a first time diagnosis of cancer of the breast or head and neck with MFW;
  • (2)Are at least more than 18 years of age or older, in order to focus the study on an adult population
  • (3)Present at malignant fungating wound more than one month old;
  • (4)Are able to speak and understand Chinese, in order to understand the consent form and the intervention and complete the study questionnaires

Exclusion Criteria:

  • (1) patients conscious unclear;
  • (2) Had seriously medical or psychology, such as hemodialysis;
  • (3) Had other comorbidity may interfere with intervention ion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00813631

Contact: We-Yu Hu 886-22123456 ext 8848

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Study Chair: We-Yu Hu National Taiwan University Hospital

Responsible Party: We-Yu Hu, National Taiwan University Identifier: NCT00813631     History of Changes
Other Study ID Numbers: 200804050R
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: May 19, 2009
Last Verified: March 2009

Keywords provided by National Taiwan University Hospital:
Malignant fungating wound
Head and neck
Ionic silver-releasing dressing
Wound care

Additional relevant MeSH terms:
Wounds and Injuries
Head and Neck Neoplasms
Neoplasms by Site
Carboxymethylcellulose Sodium
Gastrointestinal Agents