An interventional study of VACUTEX™ wound dressing and Octenisept® wound care dressing in Wound Healing Time and Total Hip Arthroplasty (THA), sponsored by Clinical Center of Vojvodina. Recruiting at 1 site in Serbia. Open to participants aged 65 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Clinical Center of Vojvodina · Not applicable, Interventional, and Treatment
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.
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's planned enrollment of 90 is above the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Clinical Center of Vojvodina is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Patients receive wound care using the VACUTEX™ capillary action dressing system with dressing changes performed every 4 days until wound closure (suture removal).
Device: VACUTEX™ wound dressing
Patients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 3 days until wound closure (suture removal).
Procedure: Octenisept® wound care dressing
Patients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 2 days until wound closure (suture removal).
Procedure: Octenisept® wound care dressing
A 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.
Standard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.
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)
Plan to share: No — IPD will not be shared publicly. Only aggregated and anonymized study results will be published in scientific journals and presented at conferences.
Start is estimated for Jul 2026; primary completion for Aug 2026, 1 month later.
Of 99 non-industry interventional studies with no phase under Surgical Wound, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 53. This study's planned 1 month is below that.
Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.
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Clinical Center of Vojvodina