Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

8. juli 2026 oppdatert 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

      • Novi Sad, Serbia, 21000
        • Rekruttering
        • Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to complete wound epithelialization
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

12. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere