Description

This study will be designed as a prospective, randomized, controlled clinical trial conducted at the Clinic for Orthopedic Surgery and Traumatology, University Clinical Centre of Vojvodina. A total of 90 patients undergoing primary total hip arthroplasty will be enrolled and randomly allocated into three parallel treatment groups using block randomization.

The participants will receive one of the following wound care protocols:

Group 1: VACUTEX™ capillary-action dressing, changed every 4 days until suture removal.

Group 2: Standard dressing with Octenisept® aqueous solution, changed every 3 days until suture removal.

Group 3: Standard dressing with Octenisept® aqueous solution, changed every 2 days until suture removal.

Baseline demographic and clinical data, including age, sex, body mass index (BMI), comorbidities, smoking status, previous orthopedic procedures, and preoperative laboratory parameters (blood glucose, HbA1c, and C-reactive protein), will be collected at admission.

The primary outcome will be time to complete wound epithelialization, defined as the number of days from surgery to complete wound closure without exudate, dehiscence, signs of infection, or need for additional wound interventions.

Secondary outcomes will include:

Incidence of local postoperative wound complications (surgical site infection, dehiscence, seroma, and hematoma according to CDC criteria); Postoperative pain intensity assessed using the Visual Analogue Scale (VAS); Local wound temperature; Wound exudate pH; Length of hospital stay; Time to suture removal. Initial wound assessment will be performed immediately after wound closure in the operating room (postoperative day 0). Subsequent assessments will be conducted at each scheduled dressing change according to the assigned treatment protocol. Wound temperature will be measured using a non-contact infrared thermometer, while exudate pH will be determined using a calibrated digital pH meter. Pain intensity will be evaluated at each assessment using the VAS.

Participants will be followed throughout hospitalization and during outpatient visits up to 30 days after surgery. In cases of wound-related complications, follow-up will be extended up to 90 postoperative days.

Data will be recorded in standardized case report forms and entered into a dedicated database for statistical analysis. Statistical analyses will be performed using IBM SPSS Statistics software. Appropriate parametric and non-parametric tests, repeated-measures analyses, survival analysis (Kaplan-Meier and Cox regression), and multivariable regression models will be used according to the type and distribution of the collected data. A p-value \<0.05 will be considered statistically significant.