Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272097
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-07
Brief Title:
Postoperative Difficult-to-Heal Wounds of Clinical Trial Registration
Sponsor:
Danni Feng
Organization:
Tongji Hospital
Study Overview
Official Title:
Optimization Program for the Care Management of Difficult-to-heal Postoperative Wounds Based on TIME CDST Toola Randomized Controlled Trial Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None