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NCT Number: NCT07655388

Wound Healing, Dressing Type, and Dressing Change Frequency in THA

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.

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Key information

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina

Novi Sad, 21000, Serbia

Location status: Recruiting

Location contact

Nemanja Gvozdenović, PhD, Associate Professor

CONTACT

[email protected]

+381646355614

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Revision hip arthroplasty
  • Active infection at the time of surgery
  • Immunosuppressive therapy or severe immunodeficiency
  • Known allergy to dressing materials used in the study
  • Severe peripheral vascular disease affecting wound healing
  • Inability to comply with follow-up protocol

Treatment and study plan

VACUTEX™ wound dressing

Device

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.

Octenisept® wound care dressing

Procedure

Standard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.

Primary outcomes

  1. Time to complete wound epithelialization

    Time frame: Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrijana Ćorić, MScN

CONTACT

[email protected]

+381611810756

Nemanja Gvozdenović, PhD, Associate Professor

CONTACT

[email protected]

+381646355614

Sponsors and collaborators

Lead sponsor

Clinical Center of Vojvodina

Other

Registry information

Official study title

Impact of Dressing Type and Dressing Change Frequency on Surgical Wound Healing Following Primary Total Hip Arthroplasty

Acronym: CAP-HIP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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