Postoperative Wounds With Delayed Healing Risk of Clinical Trial Registration

NCT ID: NCT06272097

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 492 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

Brief Summary

this study aims to optimize the components of TIME CDST based on clinical practice and apply the optimized elements to the management of wounds with delayed healing risk after hip arthroplasty to identify and design the key steps in the clinical application of TIME CDST. 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 postoperative wounds with delayed healing risk in clinical practice, thereby improving patient outcomes and quality of life.

Detailed Description

1. Research Background and Objectives Orthopedic surgical wounds present more complex healing challenges compared to other surgical wounds. Hip arthroplasty is the most common type of orthopedic surgery. Due to surgical complexity or patient-specific factors, this procedure is particularly prone to surgical complications such as surgical site infection, wound dehiscence, tissue necrosis, and hematoma, thereby increasing the risk of delayed wound healing postoperatively.To improve the healing outcomes of postoperative wounds with delayed healing, optimizing nursing management protocols is crucial. This study aims to optimize nursing management for wounds with delayed healing risk after hip arthroplasty using the TIME CDST tool and validate its effectiveness.

2. Research Methods Study Design: This study employed a randomized controlled trial design, randomly assigning participants to an experimental group and a control group, which received different nursing management protocols.

Sample Size: A total of 492 patients are expected to be included, with 246 in the experimental group and 246 in the control group.

Intervention Measures: Patients in the experimental group will receive nursing management based on the TIME CDST tool, while those in the control group will receive conventional nursing management.

Evaluation Indicators: The primary outcome measure is wound healing time. Secondary outcome measures include the number of cases with wound healing, wound area reduction rate, ASEPSIS wound scoring system, Stone-Brock Scar Scoring Scale (SBSES), Visual Analog Scale (VAS), patient comfort score, patient satisfaction score, albumin levels, dressing change frequency, and medical costs.Clinical adverse events will be recorded for safety assessment.

Data collection and analysis: Data will be collected through questionnaire surveys, observation records, statistical analysis, and comparative analysis.

3. Study process Screening and grouping: Patients meeting the inclusion criteria will be screened and randomly assigned to the experimental group and control group.

Intervention Implementation: The experimental group will receive a nursing management plan based on the TIME CDST tool, while the control group will receive routine nursing management.

Follow-up and Evaluation: Regularly assess patients' wound conditions, record healing status, and collect patient satisfaction data.

Data Analysis: Analyze the collected data and compare differences between the experimental group and the control group in terms of various assessment indicators.

Result Interpretation and Report Writing: Based on the data analysis results, draw conclusions and write the research report.

4. Expected Results

Through the implementation of this study, the researchers expect to draw the following conclusions:

The nursing management plan based on the TIME CDST tool can significantly shorten the wound healing time after hip replacement surgery.

This plan can improve the wound healing rate after hip replacement surgery. This plan can enhance patient satisfaction with nursing services. This plan has practical application and promotion value in clinical practice.

5. Significance and Value of the Study This study holds significant importance and value for optimizing nursing management of wounds with delayed healing risk. Through scientific experimental design and rigorous data analysis, researchers can provide effective nursing management strategies for clinical practice, thereby improving patient outcomes and quality of life. Additionally, the findings of this study can serve as a reference and inspiration for other similar studies, contributing to the advancement and development of the nursing management field.

Conditions

Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change.

Group Type: EXPERIMENTAL

Intervention program based on TIME-CDST tool led by wound specialist nurses

Intervention Type: BEHAVIORAL

Based on the TIME CDST tool led by wound specialist nurses, which includes the following five 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; E. Evaluate and reassess the treatment and wound management outcomes; Give patients health education on wound care management.

Control group

The control group receives a routine wound care program of wound cleaning and dressing changes at each dressing change.

Group Type: OTHER

A routine wound care program

Intervention Type: BEHAVIORAL

A routine wound care program of wound cleaning and dressing changes

Interventions

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 five 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; E. Evaluate and reassess the treatment and wound management outcomes; Give patients health education on wound care management.

Intervention Type: BEHAVIORAL

A routine wound care program

A routine wound care program of wound cleaning and dressing changes

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age ≥18 years;
• First-time recipient of unilateral total HA or hemiarthroplasty;
• Postoperative wound healing delay risk, defined as epithelialization <50% at 2 weeks postoperatively (quantified using a standardized manual planar measurement method: on day 14 postoperatively, a (quantified using a standardized manual planar measurement method: on day 14 postoperatively, a standardized transparent grid membrane with 1mm² graduations is placed vertically over the wound, and the wound perimeter and epithelialization boundary are marked with a surgical marker. boundary are marked with a surgical marker pen; the epithelialized area is defined as pink, non-exudative tissue completely covering the dermis); Normal cognitive and communication abilities;
• Ability to comply with relevant nursing measures;
• Voluntary participation in this trial
• Voluntary participation in this trial and signed informed consent form.

Exclusion Criteria

• Active infection at the surgical site prior to initial hip surgery; Deep surgical site infection (SSI) or periprosthetic joint infection (PJI) diagnosed or strongly suspected at screening. diagnosed or strongly suspected at screening (based on clinical symptoms, imaging, or aspiration results according to the MSIS/EBJIS criteria);
• Complete wound dehiscence (>2 cm) or exposure of the prosthesis/bone cement, requiring emergency revision surgery;
• Severe vascular insufficiency (ABI <0.5 cm);
• Severe acute and chronic chronic disease (ABI <0.5 cm) insufficiency (ABI <0.6, severe limb ischemia);
• Uncontrolled systemic conditions severely impairing healing potential: severe malnutrition or obesity (BMI≥ 40 kg/m² or≤ 16 kg/m² or serum albumin <2.5 g/dL); Uncontrolled diabetes (HbA1c >9% in the past 3 months); severe heart failure (NYHA IV); severe liver dysfunction (Child-Pugh C); severe renal failure requiring dialysis; active malignant tumors; immunosuppressive therapy (high-dose corticosteroids >10 mg prednisolone); and dose corticosteroids >10 mg prednisone equivalent/day, biologics, or immunosuppressive agents following transplantation).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danni Feng

OTHER

Sponsor Role: lead

Responsible Party

Danni Feng

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Danni Feng

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Central Contacts

Danni Feng

Role: CONTACT

992911819@qq.com

0086-13476022370

Other Identifiers

201328

Identifier Type: -

Identifier Source: org_study_id