Inoperable Malignant WoundsNCT07556146
Dressing Methods in Inoperable Malignant Wounds
A study testing PHMB-containing dressing and Paraffin tulle dressing in people with Inoperable Malignant Wounds, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inoperable Malignant Wounds
- What is being tested?
- PHMB-containing dressing and Paraffin tulle dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with acute wounds
- Patients with incomplete follow-up
- Patients with conditions preventing adherence to the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Inoperable Malignant Wounds
- Being tested
- PHMB-containing dressing, Paraffin tulle dressing
- Keywords
- malignant wound, palliative wound care, polyhexamethylene biguanide, oncology patients, symptom management, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHMB-containing dressingOther
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 dressingOther
Paraffin-based tulle dressings containing chlorhexidine were applied as part of standard wound care throughout the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| PHMB Group | Experimental | Participants received PHMB-containing dressings. Receives: Other: PHMB-containing dressing |
| Paraffin Tulle Group | Active comparator | Participants received paraffin-based tulle dressings containing chlorhexidine. Receives: Other: Paraffin tulle dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start30 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable Malignant WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Collaborators
- Sakarya University Education and Research Hospital
- Responsible party
- Sponsor
- Investigators
- HANDE CENGİZ AÇIL, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556146
- Sponsor's protocol ID
- E-16214662-050-01004-310645
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07556146
- Acronym / sponsor ID
- E-16214662-050-01004-310645
- Conditions
- Inoperable Malignant Wounds
- Keywords
- malignant wound, palliative wound care, polyhexamethylene biguanide, oncology patients, symptom management, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Collaborators
- Sakarya University Education and Research Hospital
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PHMB Group | Experimental | Other: PHMB-containing dressingParticipants received PHMB-containing dressings. |
| Paraffin Tulle Group | Active comparator | Other: Paraffin tulle dressingParticipants received paraffin-based tulle dressings containing chlorhexidine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with acute wounds
- Patients with incomplete follow-up
- Patients with conditions preventing adherence to the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHMB-containing dressingPHMB-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. | Other | PHMB Group |
| Paraffin tulle dressingParaffin-based tulle dressings containing chlorhexidine were applied as part of standard wound care throughout the follow-up period. | Other | Paraffin Tulle Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HANDE CENGİZ AÇIL principal investigator
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHMB-containing dressing and Paraffin tulle dressing in people with Inoperable Malignant Wounds, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom burden measured by the Edmonton Symptom Assessment Scale (ESAS) (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.