Inoperable Malignant Wounds
Conditions
Keywords
malignant wound, palliative wound care, polyhexamethylene biguanide, oncology patients, symptom management, quality of life
Brief summary
This randomized controlled study aimed to evaluate symptom burden and quality of life in oncology patients with inoperable malignant wounds. Patients were assigned to receive either polyhexamethylene biguanide (PHMB)-containing dressings or paraffin-based tulle dressings. Symptom severity and quality of life were assessed over a three-month follow-up period using standardized measures, including the Edmonton Symptom Assessment Scale (ESAS). The study primarily focuses on palliative outcomes rather than wound healing.
Detailed description
Malignant or inoperable wounds are complex clinical conditions frequently encountered in oncology and palliative care settings. These wounds are associated with multiple distressing symptoms, including pain, exudate, infection, malodor, and psychological burden, all of which significantly impair patients' quality of life. This randomized controlled study was conducted to evaluate symptom burden and quality of life in oncology patients with inoperable malignant wounds. The study was carried out at the Wound Care Clinic of Sakarya University Training and Research Hospital between December 2023 and June 2024. A total of 31 patients who met the inclusion criteria were enrolled and randomly assigned to two groups. The experimental group received dressings containing polyhexamethylene biguanide (PHMB), while the control group received paraffin-based tulle dressings containing chlorhexidine. Standard wound care procedures, including wound cleansing and debridement, were applied to all patients prior to dressing application. Data were collected using the Patient Information Form, Wound Care Form, and the Edmonton Symptom Assessment Scale (ESAS). Symptom burden, quality of life, and selected clinical parameters, including inflammatory markers (C-reactive protein and erythrocyte sedimentation rate), were evaluated at baseline, at the first week, first month, and third month of follow-up. The primary aim of the study was to assess changes in symptom burden and patient-reported outcomes, with a particular focus on palliative care indicators rather than wound healing.
Interventions
OTHERPHMB-containing dressing
PHMB-containing dressings were applied following standard wound care procedures, including wound cleansing and debridement, and continued regularly during the follow-up period according to clinical practice.
OTHERParaffin tulle dressing
Paraffin-based tulle dressings containing chlorhexidine were applied as part of standard wound care throughout the follow-up period.
Sponsors
Sakarya University
Sakarya University Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No masking was applied in this study. Both participants and investigators were aware of the assigned interventions.
Intervention model description
Participants were randomly assigned to one of two parallel groups to receive either PHMB-containing dressings or paraffin-based tulle dressings, and outcomes were assessed over a three-month follow-up period.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18 years and older * Diagnosed with cancer and having inoperable malignant wounds * Admitted to the wound care clinic * Able to provide informed consent
Exclusion criteria
* Patients with acute wounds * Patients with incomplete follow-up * Patients with conditions preventing adherence to the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptom burden measured by the Edmonton Symptom Assessment Scale (ESAS) | Baseline to 3 months | Symptom burden was assessed using the Edmonton Symptom Assessment Scale at baseline, 1 week, 1 month, and 3 months. The Edmonton Symptom Assessment System is a validated tool for assessing 9 common symptoms in palliative care-pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath. Patients/caregivers rate each symptom from 0 (absent) to 10 (worst possible) based on the current moment, assisting with symptom management. ESAS-r Scoring and Interpretation Scale: Each symptom is scored from 0 (no symptom) to 10 (worst possible severity). Severity Cut-offs: Generally, scores are interpreted as: 0: None 1-3: Mild 4-6: Moderate 7-10: Severe |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORHANDE CENGİZ AÇIL
Sakarya University
Outcome results
None listed