Clinical trial NCT06272097: Postoperative Difficult-to-Heal Wounds of Clinical Trial Registration
Official title: Optimization Program for the Care Management of Difficult-to-heal Postoperative Wounds Based on TIME CDST Tool：a Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wound Heal
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Wound healing time
timeFrame: 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.
Secondary outcomes:
measure: The wound healing rate
timeFrame: At 1, 2, 4, 6 and 8 weeks after the intervention begins
measure: The rate of wound area reduction
timeFrame: At 1, 2, 4, 6 and 8 weeks after the intervention begins
measure: The Pressure Ulcer Scale for Healing (PUSH)
timeFrame: At 1, 2, 4, 6 and 8 weeks after the intervention begins
measure: The positive rate of bacterial culture
timeFrame: At 1, 2, 4, 6 and 8 weeks after the intervention begins
measure: The pain intensity
timeFrame: At 1, 2, 4, 6 and 8 weeks after the intervention begins
measure: Patient comfort score
timeFrame: At 1, 2, 4, 6 and 8 weeks after the intervention begins
measure: Patient satisfaction score
timeFrame: At 1, 2, 4, 6 and 8 weeks after the intervention begins
measure: The levels of albumin
timeFrame: At 1, 2, 4, 6 and 8 weeks after the intervention begins
measure: The number of dressing changes
timeFrame: 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.
measure: Medical costs
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Danni Feng
role: PRINCIPAL_INVESTIGATOR
References: