A Comparative Study to Assess the Efficacy of Postoperative Dressing in the Prevention of Early Surgical Site Complication and Facilitation of Early Mobilization After Orthopaedic Surgeries on Hip and Knee
A Comparative Study to Assess the Efficacy of Postoperative Dressing in the Prevention of Early Surgical Site Complication and Facilitation of Early Mobilization After Orthopaedic Surgeries on Hip and Knee
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial
Objective:
The primary objective of this study is to evaluate and compare the efficacy of advanced wound dressings versus traditional gauze-based dressings in post-operative orthopedic care. The study aims to assess various parameters including patient comfort, pain management, ease of application, exudate management, and the incidence of early surgical site complications.
Title: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care: A Randomized Controlled Trial
Brief Summary:
This study aims to compare the efficacy of advanced wound dressings with traditional gauze-based dressings in post-operative orthopedic care. The study evaluates patient comfort, pain management, ease of application, exudate management, and the incidence of early surgical site complications.
Study Type: Interventional (Clinical Trial)
Study Design: Randomized Controlled Single-Centre Open-Label Study
Primary Purpose: Treatment
Study Start Date: August 10, 2022
Study Completion Date: December 10, 2022
Primary Completion Date: December 10, 2022
Estimated Enrollment: 320 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Interventions:
Participants undergoing orthopedic surgical procedures were randomized into four groups:
Group A: Aquacel Ag (Hydrofibre wound dressing with ionic silver) Group B: OPSITE (Transparent waterproof cotton pad with high Moisture Vapour Transmission Rate) Group C: MEPILEX POST OP BORDER (4-layer foam dressing with flex technology) Group D: Traditional dressing with gauze pieces, surgical pads, and porous paper adhesive strips
Objectives:
To assess the incidence of early surgical site complications such as blisters, infection, maceration, rashes, redness, swelling, and dehiscence at days 3, 7, and 14.
To determine the pain and discomfort experienced by patients during dressing changes using a visual analog scale.
To evaluate the ability to perform activities of daily living comfortably. To assess nurses' ease of application and removal of the dressings.
Outcome Measures:
Primary Outcome Measures: Incidence of surgical site complications at days 3, 7, and 14.
Secondary Outcome Measures: Pain levels during dressing changes, comfort and mobility in daily activities, ease of application and removal of the dressings, and patient satisfaction.
Data Collection Methods:
Data were collected using a semi-structured questionnaire validated by experts. The questionnaire included a wound assessment checklist, a 10-point Likert scale for patient comfort and mobility, a Visual Analog Scale for pain, and a rating scale for nurses' ease of application and removal.
Statistical Analysis:
Categorical variables were presented as numbers and percentages. Continuous variables were presented as mean ± SD and median values. Data normality was checked using the Kolmogorov-Smirnov test. Quantitative variables were analyzed using ANOVA and Kruskal-Wallis test with post hoc tests as appropriate.
Qualitative variables were analyzed using the Chi-Square test or Fisher's exact test for cells with expected values less than 5.
A p-value of less than 0.05 was considered statistically significant.
Ethics and Registration:
Detailed Description:
This study evaluates the comparative efficacy of different wound dressings used in post-operative orthopedic care. The focus is on advanced dressings such as Aquacel Ag, OPSITE, and MEPILEX POST OP BORDER, compared to traditional gauze-based dressings. The study measures various parameters including patient comfort, pain during dressing changes, ease of application and removal by nurses, and management of wound exudate. Data were collected at three time points: days 3, 7, and 14 post-surgery. The results aim to provide insights into the best practices for post-operative wound management in orthopedic patients.
Inclusion Criteria:
Exclusion Criteria: