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

NCT07655388 | Recruiting

• 1 other identifier: 00-37/20
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Healing Time; Total Hip Arthroplasty (THA)

Keywords

Wound Dressing; VACUTEX; Dressing Change Frequency; Primary Total Hip Arthroplasty; Surgical Wound; Wound Healing; Exudate pH; Wound Temperature; Postoperative Pain; Orthopedic Surgery; Nursing; Surgical Site Infection; Epithelialization; Wound Care

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (3)

VACUTEX™ group

EXPERIMENTAL

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

Standard dressing - 3-day change

ACTIVE COMPARATOR

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

Standard dressing - 2-day change

ACTIVE COMPARATOR

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

Interventions

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.

VACUTEX™ group

Octenisept® wound care dressing PROCEDURE

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

Standard dressing - 2-day change; Standard dressing - 3-day change

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Center of Vojvodina: lead

Study Sites (1)

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

Novi Sad, 21000, Serbia

RECRUITING

Related Publications (5)

• Tatarusanu SM, Lupascu FG, Profire BS, Szilagyi A, Gardikiotis I, Iacob AT, Caluian I, Herciu L, Gisca TC, Baican MC, Crivoi F, Profire L. Modern Approaches in Wounds Management. Polymers (Basel). 2023 Sep 4;15(17):3648. doi: 10.3390/polym15173648.

  PMID: 37688274 BACKGROUND

• Liu H, Zhang G, Wei A, Xing H, Han C, Chang Z. Effect of negative pressure wound therapy on the incidence of deep surgical site infections after orthopedic surgery: a meta-analysis and systematic review. J Orthop Surg Res. 2024 Sep 9;19(1):555. doi: 10.1186/s13018-024-05038-7.

  PMID: 39252068 BACKGROUND

• Garofalo S, Morano C, Bruno L, Pagnotta L. A Comprehensive Literature Review for Total Hip Arthroplasty (THA): Part 2-Material Selection Criteria and Methods. J Funct Biomater. 2025 May 18;16(5):184. doi: 10.3390/jfb16050184.

  PMID: 40422848 BACKGROUND

• Landen NX, Li D, Stahle M. Transition from inflammation to proliferation: a critical step during wound healing. Cell Mol Life Sci. 2016 Oct;73(20):3861-85. doi: 10.1007/s00018-016-2268-0. Epub 2016 May 14.

  PMID: 27180275 BACKGROUND

• Masson-Meyers DS, Andrade TAM, Caetano GF, Guimaraes FR, Leite MN, Leite SN, Frade MAC. Experimental models and methods for cutaneous wound healing assessment. Int J Exp Pathol. 2020 Feb;101(1-2):21-37. doi: 10.1111/iep.12346. Epub 2020 Mar 30.

  PMID: 32227524 BACKGROUND

MeSH Terms

Conditions

Surgical Wound; Pain, Postoperative; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wound Infection; Infections

Study Officials

• Andrijana Ćorić

  Faculty of Mediicne, University of Novi Sad

  PRINCIPAL INVESTIGATOR

• Nemanja Gvozdenović

  Faculty of Mediicne, University of Novi Sad; Clinic for Orthopedic Surgery and Traumatology, University Clinical Center of Vojvodina

  STUDY DIRECTOR

Central Study Contacts

Andrijana Ćorić, MScN

CONTACT

+381611810756; 912007d23@mf.uns.ac.rs

Nemanja Gvozdenović, PhD, Associate Professor

CONTACT

+381646355614; nemanja.gvozdenovic@mf.uns.ac.rs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proofessor Nemanja Gvozdenović

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)