Dressing Methods in Inoperable Malignant Wounds

Sakarya University

Status: Completed

Conditions: Inoperable Malignant Wounds

Treatments: Other: PHMB-containing dressing; Other: Paraffin tulle dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT07556146

E-16214662-050-01004-310645

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

PHMB Group

Experimental group

Description:

Participants received PHMB-containing dressings.

Treatment:

Other: PHMB-containing dressing

Paraffin Tulle Group

Active Comparator group

Description:

Participants received paraffin-based tulle dressings containing chlorhexidine.

Treatment:

Other: Paraffin tulle dressing