Trial Title:
The Effect on an Ionic Silver Dressing in Head and Neck Patients With Malignant Fungating Wound
NCT ID:
NCT00813631
Condition:
Head and Neck Neoplasms
Head and Neck Cancer
Wounds
Ulcer
Conditions: Official terms:
Head and Neck Neoplasms
Wounds and Injuries
Carboxymethylcellulose Sodium
Conditions: Keywords:
Malignant fungating wound
Head and neck
Ionic silver-releasing dressing
Wound care
RCT
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
silver-releasing dressings
Description:
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.
Arm group label:
silver-releasing dressings
Other name:
AqCel Ag,AQUACEL,AQUACEL Ag,Aq Cel
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.
Detailed description:
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 patients?
Criteria for eligibility:
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:
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Start date:
January 2009
Completion date:
November 2009
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00813631
