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

NCT00813631 | Unknown Phase 4

• 1 other identifier: 200804050R
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms; Head and Neck Cancer; Wounds; Ulcer

Keywords

Malignant fungating wound; Head and neck; Ionic silver-releasing dressing; Wound care; RCT

Outcome Measures

Primary Outcomes (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)

  Each group was followed up for two week

Secondary Outcomes (1)

• Also, the Secondary outcome measure using the modified Schulz Malignant Wound Assessment Tool (mSMWAT)

  Each group was followed up for two week

Study Arms (1)

silver-releasing dressings

EXPERIMENTAL

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

Interventions

silver-releasing dressings OTHER

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.

Also known as: AqCel Ag,AQUACEL,AQUACEL Ag,Aq Cel

silver-releasing dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Wounds and Injuries; Ulcer

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• We-Yu Hu

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

We-Yu Hu

CONTACT

886-22123456; weyuhu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2008
• First Posted: December 23, 2008
• Study Start: January 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 19, 2009

Record last verified: 2009-03

Locations

TW (1)