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.
Aquacel Ag is a Hydrofibre wound dressing composed of non-woven sodium carboxymethylcellulose fibers integrated with ionic silver. It is designed to provide a moist wound environment and has antimicrobial properties to help reduce the risk of infection. The dressing will be applied post-operatively and changed according to a standardized protocol.
OPSITE is a transparent waterproof dressing with a high Moisture Vapour Transmission Rate. It is intended to provide a protective barrier while allowing moisture vapor to escape, maintaining an optimal wound healing environment. The dressing will be applied post-operatively and changed according to a standardized protocol.
MEPILEX POST OP BORDER is a 4-layer foam dressing designed with flex technology for superior absorption and conformability. It helps manage exudate and protects the wound site. The dressing will be applied post-operatively and changed according to a standardized protocol.
Base Hospital Delhi cantt
New Delhi, India
Incidence of Early Surgical Site Complications
The primary outcome measure will be the incidence of early surgical site complications, including blisters, skin margin infection, maceration, rashes, redness, swelling, and wound dehiscence. These complications will be assessed at three time points: day 3, day 7, and day 14 post-surgery.
Time frame: Day 3, Day 7, Day 14 post-surgery
Pain Levels During Dressing Changes
Pain levels experienced by patients during dressing changes will be assessed using a Visual Analog Scale (VAS) from 0 to 10, where 0 corresponds to no pain and 10 corresponds to unbearable pain. This will be measured at day 3, day 7, and day 14 post-surgery.
Time frame: Day 3, Day 7, Day 14 post-surgery
Patient Comfort and Mobility
Patient comfort and ability to perform activities of daily living will be assessed using a 0-to-10-point scale, where 0 indicates absolute discomfort and 10 indicates no limitation due to the dressing. This will be measured at day 3, day 7, and day 14 post-surgery.
Time frame: Day 3, Day 7, Day 14 post-surgery
Nurses' Ease of Application and Removal of Dressings
Nurses will rate the ease of application and removal of the dressing using a 0-to-10-point scale, considering factors such as time taken, difficulty, and any issues encountered during the process. This will be measured at day 3, day 7, and day 14 post-surgery.
Time frame: Day 3, Day 7, Day 14 post-surgery
Patient Satisfaction Levels
Patient satisfaction with the dressing will be assessed using a structured questionnaire. This will be measured at day 14 post-surgery.
Time frame: Day 14 post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
320
Traditional dressing involves the use of gauze pieces, surgical pads, and porous paper adhesive strips. This type of dressing is commonly used in post-operative care to absorb exudate and protect the wound site. The dressing will be applied post-operatively and changed according to a standardized protocol.