Postoperative Difficult-to-Heal Wounds of Clinical Trial Registration
- Conditions
- Wound Heal
- Interventions
- Behavioral: A routine wound care programBehavioral: Intervention program based on TIME-CDST tool led by wound specialist nurses
- Registration Number
- NCT06272097
- Lead Sponsor
- Danni Feng
- Brief Summary
This study aims to investigate the effectiveness of an optimized care management protocol for refractory postoperative wounds based on the TIME CDST tool. Through a randomized controlled trial approach, the investigators will conduct a rigorous comparative analysis of the experimental group and the control group. The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change, while the control group receive a routine wound care program of wound cleaning and dressing changes at each dressing change. The main research objective is to evaluate the superiority of the experimental group compared with the control group in terms of wound healing time, healing quality, and patient satisfaction. Through the implementation of this study, the investigators expect to provide an effective optimization scheme for the management of refractory postoperative wounds in clinical practice, thereby improving patient outcomes and quality of life.
- Detailed Description
1. Research background and purpose Postoperative wound healing is one of the most common challenges in clinical nursing. Especially for difficult-to-heal wounds, the healing process may be influenced by various factors, such as the patient's physical condition, the characteristics of the wound, and the quality of nursing management. In order to improve the healing effect of difficult-to-heal postoperative wounds, optimizing nursing management plans is particularly important. The aim of this study is to optimize the nursing management of difficult-to-heal postoperative wounds using the TIME CDST tool and verify its effectiveness.
2. Research methods Research Design: This study adopted a randomized controlled trial design method, randomly dividing participants into an experimental group and a control group and receiving different nursing management plans.
Sample size: It is expected to include 144 patients, including 72 in the experimental group and 72 in the control group.
Intervention measures: Patients in the experimental group will receive a nursing management plan based on the TIME CDST tool, while patients in the control group will receive routine nursing management.
Evaluation indicators: The main evaluation indicators include wound healing rate, wound healing time, wound area reduction rate, pressure ulcer healing subscale (PUSH) score, positive bacterial culture rate, and albumin count. Secondary evaluation indicators include pain score, patient comfort, patient satisfaction, and medical costs.
Data collection and analysis: collect data through methods such as questionnaire surveys, observation records, statistical analysis, and comparative analysis.
3. Research process Screening and grouping: Patients who meet the inclusion criteria are screened and randomly assigned to the experimental group and control group.
Intervention implementation: The experimental group received a nursing management plan based on the TIME CDST tool, while the control group received routine nursing management.
Follow-up and evaluation: Regularly evaluate the patient's wound, record the healing status, and collect data on patient satisfaction.
Data analysis: Analyze the collected data and compare the differences between the experimental group and the control group in various evaluation indicators.
Result interpretation and report writing: Based on the results of the data analysis, draw conclusions and write research reports.
4. Expected results
Through the implementation of this study, the investigators expect to draw the following conclusions:
The nursing management plan based on the TIME CDST tool can significantly shorten the healing time of difficult-to-heal postoperative wounds.
This plan can improve the healing rate of difficult-to-heal postoperative wounds.
This plan can improve patient satisfaction with nursing services. This plan has the value of promotion and application in clinical practice.
5. Research significance and value This study has important significance and value in optimizing the nursing management of difficult-to-heal postoperative wounds. Through scientific experimental design and rigorous data analysis, the investigators can provide an effective nursing management plan for clinical practice, improving the prognosis and quality of life of patients. In addition, the results of this study can provide reference and inspiration for other similar studies, promoting progress and development in the field of nursing management.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 144
- age ≥18 years;
- wound healing time after surgery more than 2 weeks;
- patients have normal cognitive and communication skills;
- patients are able to cooperate with relevant nursing measures;
- patients voluntarily participate in this trial and sign the informed consent form.
- patients are severe malnutrition or obesity;
- patients combine with other infectious diseases;
- patients with comorbid malignancies, severe endocrine and hematologic diseases;
- patients combine with heart, liver, kidney and other organ dysfunction;
- patients combine with autoimmune diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group A routine wound care program The control group receives a routine wound care program of wound cleaning and dressing changes at each dressing change. Intervention group Intervention program based on TIME-CDST tool led by wound specialist nurses The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change.
- Primary Outcome Measures
Name Time Method Wound healing time The time frame is from the date of intervention until the date of the complete healing of the wound or date of death from any cause, whichever came first, assessed up to 6 months. Wound healing time will be assessed as the primary outcome indicator. Complete epithelialization of the wound is considered as wound healing and the time taken from enrollment to complete wound healing will be recorded for both groups.
- Secondary Outcome Measures
Name Time Method The rate of wound area reduction At 1, 2, 4, 6 and 8 weeks after the intervention begins The rate of wound area reduction will be calculated through the following expression: (original wound area - present wound area)/original wound area × 100%. The accuracy of wound area measurements can be improved by placing a uniform wound measuring tape on one side of the wound and taking a picture of the wound area using image processing and analysis with Image J software (National Institutes of Health, Bethesda, MD).
The levels of albumin At 1, 2, 4, 6 and 8 weeks after the intervention begins Albumin count
The positive rate of bacterial culture At 1, 2, 4, 6 and 8 weeks after the intervention begins The positive rate of bacterial culture in each group will be calculated through the following expression: current number of positive bacterial culture cases/ total number of cases × 100%.
Patient comfort score At 1, 2, 4, 6 and 8 weeks after the intervention begins Use a self-made nursing comfort questionnaire to evaluate the patient's nursing comfort. The questionnaire was conducted on a 10 point scale, with scores\>9 indicating extreme comfort, 8-9 indicating relative comfort, 6-7 indicating basic comfort, and\<6 indicating discomfort.
Patient satisfaction score At 1, 2, 4, 6 and 8 weeks after the intervention begins Use a self-made nursing satisfaction questionnaire to evaluate the patient's nursing satisfaction. Both questionnaires were conducted on a 10 point scale, with scores\>9 indicating very satisfied, 8-9 indicating relative satisfaction, 6-7 indicating basic satisfaction, and\<6 indicating dissatisfaction.
The wound healing rate At 1, 2, 4, 6 and 8 weeks after the intervention begins The wound healing rate will be measured by using the number of wound healing cases during the follow-up period/total number of cases × 100%.
The Pressure Ulcer Scale for Healing (PUSH) At 1, 2, 4, 6 and 8 weeks after the intervention begins The Pressure Ulcer Scale for Healing (PUSH) will objectively and dynamically assess the healing of all types of acute and chronic wounds in terms of wound area, the amount of exudate, and the type of wound tissue, with scores ranging from 0 to 17, with a decreasing total score implying that treatment is effective, an increasing total score implying that wound deterioration is occurring, and an unchanged total score implying that treatment is ineffective.
The pain intensity At 1, 2, 4, 6 and 8 weeks after the intervention begins The pain intensity is evaluated using the visual analogue scale (VAS). In the absence of pain, a score of 0 represents a painless state; a score of 1 to 3 represents mild pain; a score of 4 to 6 represents moderate pain; and a score of 7 to 10 represents severe pain.
The number of dressing changes The time frame is from the date of intervention until the date of the complete healing of the wound or date of death from any cause, whichever came first, assessed up to 6 months. The number of dressing changes
Medical costs The time frame is from the date of intervention until the date of the complete healing of the wound or date of death from any cause, whichever came first, assessed up to 6 months. Medical cost expenditure