Postoperative Wounds With Delayed Healing Risk of Clinical Trial Registration

NCT06272097 | Not Yet Recruiting

• 1 other identifier: 201328
• Study Type: interventional
• Target: 492
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• 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 to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.

Secondary Outcomes (10)

• Number of cases with wound healing

  The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.

• The rate of wound area reduction

  The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.

• ASEPSIS wound scoring system

  The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.

• Stony Brook Scar Evaluation Scale (SBSES)

  The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.

• The pain intensity

  The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.

Other Outcomes (1)

• Safety evaluation

  The time frame is from the date of intervention to the date of complete wound healing or the outcome endpoint, whichever comes first, with an assessment period of 6 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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

Control group

OTHER

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

Behavioral: A routine wound care program

Interventions

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

Intervention group

A routine wound care program BEHAVIORAL

A routine wound care program of wound cleaning and dressing changes

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Danni Feng: lead

Study Officials

• Danni Feng

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danni Feng

CONTACT

0086-13476022370; 992911819@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 22, 2024
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share