Know Cancer

forgot password

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

Phase 4
18 Years
Open (Enrolling)
Head and Neck Neoplasms, Head and Neck Cancer, Wounds, Ulcer

Thank you

Trial Information

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

Introduction. At the beginning of the 21st century, cancer is increasing in the aging
population and patients often have a greater life expectancy than they did 40 years ago
(Payne et al 2004). As people age, and the incidence of cancer increases, it is essential to
push the frontiers of oncology care to meet the symptom management needs of these patients.
For many, cancer has become a slowly progressive, chronic disease - a change that brings
with it particular challenges for oncology nurses (Hoskin and Makin 1998). 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. This study is designed to
assess the effects of ionic silver dressing (AQUACEL Ag) in head and neck patients with
malignant fungating wound (MFW) on the quality of life, symptom distress and wound bed
changed of patients with MFW

Definition of MFW. Malignant Fungating wounds arise as a result of infiltration of the
structures of the skin by malignant cells. These cells may arise from primary skin cancer,
an underlying malignant tumor or through metastasis spread from a distant malignant
tumor(Punder, 1998).A fungating cancer is a primary or secondary malignant growth in the
skin which has ulcerated and results in pain, exudates, bleeding, infection and
malodour(Twycross, 1995) .A malignant tumor will invade and destroy adjacent tissues and can
spread to other tissues with in cells that break off and travel in the blood or lymph
system. It can develop its own blood supply, sometime outgrowing it and causing the tumor to
become necrotic in the middle(Mera, 1997).Dealey(1994) states that, as the tumor extends,
capillaries rupture, leading to epithelium results in ulceration through the skin, and
lesions presents as a fungating, foul-smelling mass(Daeley, 1994).Fungating malignant wounds
are caused by the infiltration of the skin and its supporting blood and lymph vessels by a
local tumor or as a result of metastasis growth from the primary tumor. Unless the
malignant cells are checked by single or combination cancer treatments the fungation extends
with the potential for causing massive damage at the wound site through a combination of
proliferate growth, loss of vascularity and ulceration(Mortimer, 1998) .A fungating wound is
defined as a cancerous lesion involving the skin, which is open and may be draining. The
lesion may be result of a primary cancer or metastasis to the skin from a local tumor or
from a tumor in a distant site. It may take the form of a cavity, an open area on the
surface of the skin, skin nodules, or a nodular growth extending from the surface of the
skin(British Columbia Cancer Agency, 2001) .As the malignant cells multiply in the skin they
form a tumour that enlarges causing disruption of skin capillaries and lymph vessels,
eventually leading to tissues Hypoxia and subsequent skin necrosis.

Infection control of MFW. All chronic wounds contain bacteria. Kingsley(2003) state that the
change in numbers of bacteria and the body's response as a continuum, rating from
contamination to infection(Kingsley, 2003). Contamination is mean that the bacteria present
on the wound surface but are not proliferating and have no clinic effect; colonised imply
bacteria have proliferated, but there is no host reaction; critical colonisation occurs
where the body's local host response starts to be initiated, but there are no systemic sign
of infection; Infection is point in time when the bacteria have multiplying and invaded
deeper tissues, healing is impaired and produced a systemic host reaction(Jacqui. Fletcher,
2005; Verdu Soriano , Rueda Lopez, Martinez Cuervo, & Soldevilla Agreda 2004) .

Clinical recognition of these rating stages is not easy because there are no clear
descriptors. However, Soriano et al (2004) defined classification according to the number of
bacteria present in the wound bed: Contamination-≦103 colony-forming unit (CFUs) per gram of
tissues; colonised -≦104 CFUs ; Infection -≧105 CFUs. Cutting and White noted several
aspects of wound infection such as: serous drainage with concurrent inflammation,
discoloured granulation tissue, pocketing at the wound base, unexpected pain , foul odour,
increase in exudates, exudates that becomes purulent instead of serous, and wound
breakdown(White & Cutting, 2006).

In the MFW, the presence of hypoxic necrotic tissues within the wound provides an excellent
medium for growth of aerobic and anaerobic bacteria(J. Clark, 2002). Anaerobic and aerobic
bacteria thrive in these conditions, giving rise to excessive malodour wound
exudates(Haisfield-Wolfe & Rund 1997). Lo et al (2006) survey of seventy cancer patients
with MFW in Taiwan, the study found that the 60.3% wound bed presented necrotic tissue ;
malodour was present in 50% of patients ; 81.4% shows moderate to large exudates and 71.4%
reported purulent(Lo, 2006). According above the data, infection has emerged as a major
health problem during the patient suffers MFW.

Ionic silver dressing. Silver, in its common ionic (active) form (Ag+), is particularly
attractive as an antibacterial agent because it can be readily incorporated into dressing
materials. When the materials contact an aqueous environment, the silver complex contained
in them is dissociated (Ovington 2004, White & Cutting 2006). The mechanism of action for
Ag+ is that it binds to bacterial cell DNA, and enzymes, and proteins in the cell wall. Once
the silver cation attaches to these sites, it alters their structure, resulting in
structural and functional changes in the bacterial cell (Ovington 2004).It is suggested by
numerous authors that silver dressings should be utilized when critical colonization within
a wound occurs (Ovington 2004, White & Cutting 2006, Lo et al 2008). Therefore, this study
research questions is (1)What are the effects of ionic silver dressing (AQUACEL Ag)in head
and neck patients with malignant fungating wound, as compared to hydrofiber
dressing(AQUACEL), on the individual perception subjective quality of life?(2) What are the
effects of ionic silver dressing (AQUACEL Ag) in head and neck patients with malignant
fungating wound, as compared to hydrofiber dressing (AQUACEL) alone, on the symptom distress
and wound bed changed of patients receiving ionic silver dressing (AQUACEL Ag) for cancer

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:

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

The data are collected using questionnaires completed by the subjects themselves.In this study , the primary outcome is health-related quality of life (HRQOL)

Outcome Time Frame:

Each group was followed up for two week

Safety Issue:


Principal Investigator

We-Yu Hu

Investigator Role:

Study Chair

Investigator Affiliation:

National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

January 2009

Completion Date:

November 2009

Related Keywords:

  • Head and Neck Neoplasms
  • Head and Neck Cancer
  • Wounds
  • Ulcer
  • Malignant fungating wound
  • Head and neck
  • Ionic silver-releasing dressing
  • Wound care
  • RCT
  • Neoplasms
  • Head and Neck Neoplasms
  • Ulcer