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Completed

NCT Number: NCT07556146

Dressing Methods in Inoperable Malignant Wounds

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.

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Key information

Conditions

Inoperable Malignant Wounds

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya Uni

Sakarya, Serdi̇van, 54000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PHMB-containing dressing

Other

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 tulle dressing

Other

Paraffin-based tulle dressings containing chlorhexidine were applied as part of standard wound care throughout the follow-up period.

Primary outcomes

  1. Change in symptom burden measured by the Edmonton Symptom Assessment Scale (ESAS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Collaborators

  • Sakarya University Education and Research Hospital

Registry information

Official study title

Comparison of PHMB-containing Dressings and Paraffin-based Tulle Dressings in the Management of Inoperable Malignant Wounds in Oncology Patients: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.