An interventional study of PHMB-containing dressing and Paraffin tulle dressing in Inoperable Malignant Wounds, sponsored by Sakarya University. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Sakarya University · Not applicable, Interventional, and Supportive care
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.
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.
Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received PHMB-containing dressings.
Other: PHMB-containing dressing
Participants received paraffin-based tulle dressings containing chlorhexidine.
Other: Paraffin tulle 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.
Paraffin-based tulle dressings containing chlorhexidine were applied as part of standard wound care throughout the follow-up period.
Change in symptom burden measured by the Edmonton Symptom Assessment Scale (ESAS)
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
Time frame: Baseline to 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Sakarya University