Postoperative Wounds With Delayed Healing Risk of Clinical Trial Registration
ConditionWound Heal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDanni Feng
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention program based on TIME-CDST tool led by wound specialist nurses
BehavioralBased 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.
A routine wound care program
BehavioralA routine wound care program of wound cleaning and dressing changes
Treatment groups
492 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
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.
Time frame
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
1
Number of cases with wound healing
The number of cases in which the wound will be completely epithelialized (defined as pink, non-exudative tissue completely covered by epithelium) during the period from enrollment to the endpoint
Time frame
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.2
The rate of wound area reduction
The rate of wound area reduction will be calculated through the following expression: (original wound area - present wound area)/original wound area × 100%. The accuracy of wound area measurements can be improved by placing a uniform wound measuring tape on one side of the wound and taking a picture of the wound area using image processing and analysis with Image J software (National Institutes of Health, Bethesda, MD).
Time frame
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.3
ASEPSIS wound scoring system
The ASEPSIS wound scoring system will be used to assess surgical wound infection and healing. This evaluation criteria primarily evaluates multiple aspects including wound characteristics, antibiotic use, wound drainage, local debridement, bacterial culture, hospital stay, and home care of the wound. A higher score indicates more severe wound infection. (Total score: 0 to 10 indicates satisfactory healing; 11 to 20 indicates poor healing; 21 to 30 indicates mild wound infection; 31 to 40 indicates moderate wound infection; and greater than 40 indicates severe wound infection.)
Time frame
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.4
Stony Brook Scar Evaluation Scale (SBSES)
The Stony Brook Scar Evaluation Scale (SBSES) will be measured the aesthetic outcome of postoperative wounds, including five criteria: width, height, color, suture line, and overall appearance. Each criterion is scored as 0 or 1, with a total score ranging from 0 (worst) to 5 (best)
Time frame
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
Clinical events were recorded, including reasons for non-healing (infection, hematoma, abscess, wound dehiscence, rejection reaction), antibiotic treatment, readmission, reoperation, amputation, and death.
Time frame
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Danni Feng
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov
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