Postoperative Difficult-to-Heal Wounds of Clinical Trial Registration

Wound Heal Clinical Trial

Official title:

Optimization Program for the Care Management of Difficult-to-heal Postoperative Wounds Based on TIME CDST Tool：a Randomized Controlled Trial Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06272097
• Other study ID #: 201328
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: November 15, 2024

Study information

• Verified date: February 2024
• Source: Tongji Hospital
• Contact: Danni Feng
• Phone: 0086-13476022370
• Email: 992911819[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: November 15, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

Behavioral:
• Intervention program based on TIME-CDST tool led by wound specialist nurses
Based on the TIME CDST tool led by wound specialist nurses, which includes the following four areas: A. Assess patient, well-being and wound; B. Bring in multidisciplinary team and informal carers to promote holistic patient care; C. Control or treat underlying causes and barriers to wound healing; D. Decide appropriate treatment.
• A routine wound care program
A routine wound care program of wound cleaning and dressing changes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Danni Feng

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing time	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.	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	The wound healing rate	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%.	At 1, 2, 4, 6 and 8 weeks after the intervention begins
Secondary	The rate of wound area reduction	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).	At 1, 2, 4, 6 and 8 weeks after the intervention begins
Secondary	The Pressure Ulcer Scale for Healing (PUSH)	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.	At 1, 2, 4, 6 and 8 weeks after the intervention begins
Secondary	The positive rate of bacterial culture	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%.	At 1, 2, 4, 6 and 8 weeks after the intervention begins
Secondary	The pain intensity	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.	At 1, 2, 4, 6 and 8 weeks after the intervention begins
Secondary	Patient comfort score	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.	At 1, 2, 4, 6 and 8 weeks after the intervention begins
Secondary	Patient satisfaction score	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.	At 1, 2, 4, 6 and 8 weeks after the intervention begins
Secondary	The levels of albumin	Albumin count	At 1, 2, 4, 6 and 8 weeks after the intervention begins
Secondary	The number of dressing changes	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.
Secondary	Medical costs	Medical cost expenditure	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.