Construction and cost-benefit analysis of a nurse-led management model for chronic wounds in vascular surgery based on the concept of integrated care

ISRCTN	ISRCTN12259892
DOI	https://doi.org/10.1186/ISRCTN12259892
Sponsor	Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Third Hospital of Shanxi Medical University, Tongji Shanxi Hospital
Funder	Application Research of Time-point Matching Management Path Based on Pain Trajectory in ASO Patients.

Submission date: 02/06/2026
Registration date: 04/06/2026
Last edited: 02/06/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yuan Bai
Scientific, Public, Principal investigator

No. 99, Longcheng Street
Taiyuan
030032
China

Phone	+86 13934660965
Email	Baiyuan8_Yb@163.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Supportive care
Scientific title	Construction and cost-benefit analysis of a nurse-led nursing management model for chronic wound care in vascular surgery
Study objectives	To establish a nurse-led chronic wound management model for vascular surgery under the concept of integrated care, and to evaluate its impact on wound healing, medical costs, and cost-effectiveness ratio.
Ethics approval(s)	Approved 03/02/2026, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences (No. 99, Longcheng Street, Taiyuan City, Taiyuan, 030032, China; +86 351-8379146; dyyllwyh@163.com), ref: YXLL-2026-036
Health condition(s) or problem(s) studied	Nursing care for patients with chronic wounds in vascular surgery
Intervention	Control Group: Conventional Management Model The traditional diagnosis and treatment model was adopted. Responsible nurses performed dressing changes, condition observation, and basic health education. After discharge, simple telephone follow-up was implemented once a week for 4 weeks, inquiring about wound healing (e.g., exudation, pain), medication compliance, and abnormalities, providing oral guidance. Nursing behaviors were mainly based on executing medical orders, lacking systematic assessment and full-course intervention. Observation Group: Nurse-led Full-Process Management under Integrated Care Concept Based on the integrated care theory, a full-process management system was constructed, including wound specialist nurses as leaders, multidisciplinary team collaboration, continuous connection within and outside the hospital, and individualized precise intervention. Randomization process: A statistician not involved in clinical assessment and intervention independently generated the random sequence using SPSS 26.0. The random numbers were assigned according to enrolment order. Allocation concealment was ensured by sealed, opaque, sequentially numbered envelopes, opened only after baseline assessment. Both groups were treated in the same ward, but interventions were performed by different nursing teams to avoid cross-contamination. All outcome assessors were blinded to group allocation and the intervention process.
Intervention type	Other
Primary outcome measure(s)	Time to complete wound healing defined as full epithelialisation without exudate, infection, or need for dressing changes measured using Clinical wound assessment against predefined healing criteria at From first intervention to full epithelialisation Pain intensity measured using Visual Analogue Scale (VAS) at admission, discharge, and wound healing or study endpoint Wound infection occurrence measured using clinical diagnosis/medical record review at enrolment to wound healing Wound recurrence rate measured using outpatient or video follow-up assessment at 6 months Patient satisfaction with nursing service measured using self-developed nursing service evaluation scale with 10 items rated on a 5-point Likert scale at discharge or after wound healing Health economic outcomes including cost of care measured using patient records at admission to complete wound healing
Key secondary outcome measure(s)
Completion date	30/01/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Male
Target sample size at registration	360
Total final enrolment	363
Key inclusion criteria	1. Meeting the diagnostic criteria for chronic wounds, referring to the "Expert Consensus on Chronic Wound Care" issued by the Wound Ostomy Nursing Professional Committee of the Chinese Nursing Association, defining a chronic wound as a wound that has not healed within 4 weeks of standardized treatment or shows no tendency to heal 2. Age ≥18 years 3. Clear consciousness with basic communication and cooperation abilities 4. Voluntarily participating and signing informed consent
Key exclusion criteria	1. Severe functional failure of important organs (cardiac function grade IV, Child-Pugh liver function grade C, chronic kidney disease stage 5 requiring regular dialysis) 2. Malignant tumors, coagulation dysfunction, systemic infectious diseases 3. Cognitive impairment, mental illness, or inability to complete follow-up 4. Missing clinical data or withdrawal midway
Date of first enrolment	02/01/2024
Date of final enrolment	05/12/2025

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

02/06/2026: Trial's existence confirmed by Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences.