Dressing Methods in Inoperable Malignant Wounds

NCT07556146 | Completed

• 1 other identifier: E-16214662-050-01004-310645
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Inoperable Malignant Wounds

Keywords

malignant wound; palliative wound care; polyhexamethylene biguanide; oncology patients; symptom management; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to 3 months

Study Arms (2)

PHMB Group

EXPERIMENTAL

Participants received PHMB-containing dressings.

Other: PHMB-containing dressing

Paraffin Tulle Group

ACTIVE COMPARATOR

Participants received paraffin-based tulle dressings containing chlorhexidine.

Other: Paraffin tulle dressing

Interventions

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.

PHMB Group

Paraffin tulle dressing OTHER

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

Paraffin Tulle Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with acute wounds
• Patients with incomplete follow-up
• Patients with conditions preventing adherence to the study protocol

Sponsors & Collaborators

• Sakarya University: lead
• Sakarya University Education and Research Hospital: collaborator

Study Sites (1)

Sakarya Uni

Sakarya, Serdi̇van, 54000, Turkey (Türkiye)

Location

Study Officials

• HANDE CENGİZ AÇIL

  Sakarya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was applied in this study. Both participants and investigators were aware of the assigned interventions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 29, 2026
• Study Start: December 30, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)