Postoperative Wounds With Delayed Healing Risk of Clinical Trial Registration

Launched by DANNI FENG · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how to improve the healing of difficult-to-heal wounds that some patients may have after surgery. Researchers want to see if a special care plan, guided by wound care experts, can help these wounds heal faster and better compared to standard wound care. Participants in the study will be divided into two groups: one group will receive the new care plan, while the other will get the usual care. The study aims to find out which approach works better in terms of healing time, the quality of healing, and how satisfied patients are with their care.

To join this trial, participants need to be at least 18 years old and have a surgical wound that hasn’t healed for more than two weeks. They should also be able to understand and follow instructions from the nurses. However, some individuals may not be eligible, including those with serious health issues like severe malnutrition or certain diseases. If you participate, you can expect close attention from wound care specialists and regular assessments to see how your wound is healing throughout the study. The ultimate goal is to find better ways to help patients recover from their surgeries and improve their quality of life.

Gender

ALL

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).