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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00813631
First received: December 21, 2008
Last updated: May 17, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Head and Neck Neoplasms
Head and Neck Cancer
Wounds
Ulcer
Other: silver-releasing dressings
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
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)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813631

Contacts
Contact: We-Yu Hu 886-22123456 ext 8848 weyuhu@ntu.edu.tw

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

No publications provided

Responsible Party: We-Yu Hu, National Taiwan University
ClinicalTrials.gov Identifier: NCT00813631     History of Changes
Other Study ID Numbers: 200804050R
Study First Received: December 21, 2008
Last Updated: May 17, 2009
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014