Wound Healing, Dressing Type, and Dressing Change Frequency in THA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-95
SponsorClinical Center of Vojvodina
About this trial
Surgical wound complications following primary total hip arthroplasty remain a significant clinical challenge despite advances in wound care technologies. The optimal choice of dressing and frequency of dressing changes remain insufficiently investigated, particularly regarding their influence on wound healing and the wound microenvironment.
This prospective, randomized, controlled clinical trial aims to evaluate the impact of dressing type and dressing change frequency on surgical wound healing in patients undergoing primary total hip arthroplasty. Ninety patients will be allocated into three treatment groups receiving either a capillary-action dressing system (VACUTEX™) or standard dressings with different dressing change intervals.
The study will assess time to complete wound epithelialization, postoperative wound complications, pain intensity, wound temperature, exudate pH, length of hospital stay, and time to suture removal. In addition, the study will investigate the potential role of wound temperature and exudate pH as early indicators of impaired healing and postoperative complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for primary total hip arthroplasty (THA)
Age ≥ 65 years
Ability to provide informed consent
Patients with closed surgical incision suitable for standard postoperative wound care
Disqualifiers
Revision hip arthroplasty
Active infection at the time of surgery
Immunosuppressive therapy or severe immunodeficiency
Known allergy to dressing materials used in the study
Trial design
Design model
Parallel
Treatments tested in this trial
VACUTEX™ wound dressing
DeviceA capillary action-based wound management system designed for continuous removal of exudate without the use of external negative pressure, maintaining a moist wound environment and minimizing dressing adherence to the wound surface.
Octenisept® wound care dressing
Procedure/SurgeryStandard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: VACUTEX™ groupExperimental treatment 1 intervention
Group B: Standard dressing - 3-day changeActive comparator 1 intervention
Group C: Standard dressing - 2-day changeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to complete wound epithelialization
Time (in days) from surgery to complete wound epithelialization, defined as complete clinical closure of the surgical incision without exudate, dehiscence, or visible wound gaps, as assessed by clinical examination.
Time frame
Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)Sponsors and contacts
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Source ClinicalTrials.gov