Clinical trial · Interventional
Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients
Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients Based on Symptom Management Theory
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Fungating Wound | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| malignant fungating wounds care regimen | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- malignant fungating wounds care regimen
- description
- malignant fungating wounds care regimen based on the evidences, expert consultation, pre-experiment and final determination
- interventionNames
- Procedure: malignant fungating wounds care regimen
Primary outcomes (1)
- measure
- Change from Baseline in Wound Size at day 42
- timeFrame
- Baseline and day 42
- description
- described by "healing, improvement, maintenance, deterioration", where "wound healing" refers to 100% epithelialization of the wound, "wound improvement" refers to reduction of the wound area, "wound maintenance" refers to no change in the wound area, and "wound deterioration" refers to an increase in the wound area.
Secondary outcomes (6)
- measure
- Change from Baseline in Wound symptoms at day 42
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Age greater than or equal to 18 years old with pathologically confirmed diagnosis of breast cancer.
* Tumor metastasis in the chest wall or other sites and rupture to form a malignant fungating wound with a wound area of at least 10cm2 or more.
* Knowing of the cancer diagnosis. ④ Capable and willing to receive follow-up.
* Informed consent and voluntary participation.
Exclusion Criteria:
* Patients with mental illness or cognitive impairment and language expression deficiency.
* Patients with extensive metastasis of cancer throughout the body to the chest, shoulders, back, arms, etc. and whose treatment was ineffective.
* Patients at the end stage of death.
* Patients who refused to participate in this study.
Withdrawal criteria:
* Patients who developed serious complications during the study and were unable to continue the study.
* Patients who died during the study. ③Patients who requested withdrawal on their own during the study.References
Publications (0)
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