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Wound Healing, Dressing Type, and Dressing Change Frequency in THA (CAP-HIP)

8 juli 2026 uppdaterad av: Nemanja Gvozdenović, Clinical Center of Vojvodina

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

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

90

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

      • Novi Sad, Serbien, 21000
        • Rekrytering
        • Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: VACUTEX™ group
Patients receive wound care using the VACUTEX™ capillary action dressing system with dressing changes performed every 4 days until wound closure (suture removal).
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.
Aktiv komparator: Standard dressing - 3-day change
Patients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 3 days until wound closure (suture removal).
Standard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.
Aktiv komparator: Standard dressing - 2-day change
Patients receive standard wound care using Octenisept® solution with sterile dressing, with dressing changes performed every 2 days until wound closure (suture removal).
Standard postoperative wound care involving application of Octenisept® aqueous solution and sterile dressing for surgical wound management.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to complete wound epithelialization
Tidsram: 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.
Postoperative day 30 (90 or more in case of wound complications according to CDC criteria)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Andrijana Ćorić, Faculty of Mediicne, University of Novi Sad
  • Studierektor: Nemanja Gvozdenović, Faculty of Mediicne, University of Novi Sad; Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 augusti 2026

Avslutad studie (Beräknad)

1 november 2026

Studieregistreringsdatum

Först inskickad

12 juni 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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NEJ

IPD-planbeskrivning

IPD will not be shared publicly. Only aggregated and anonymized study results will be published in scientific journals and presented at conferences.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

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Nej

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