Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care
- Conditions
- Orthopaedics Wound Dressings
- Interventions
- Device: Traditional DressingDevice: Aquacel AgDevice: OPSITEDevice: MEPILEX POST OP BORDER
- Registration Number
- NCT06540040
- Lead Sponsor
- Nidhi Srivastava
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- Age between 18 and 90 years Undergoing orthopedic surgical procedures, elective or trauma, with a surgical wound size of more than 5 cm Provided informed consent
- Open fractures Revision surgeries Established infections Ongoing pharmacological anticoagulation prophylaxis Predisposing skin conditions Known allergy or hypersensitivity to any of the constituents of the dressings Any associated systemic injury precluding early mobilization Unwillingness to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional Dressing Traditional Dressing Participants in this group will receive traditional wound dressings consisting 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 the standardized protocol. Aquacel Ag Aquacel Ag Participants in this group will receive Aquacel Ag, a Hydrofibre wound dressing consisting of non-woven sodium carboxymethylcellulose fibres integrated with ionic silver. This dressing 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 as per the standardized protocol. OPSITE OPSITE Participants in this group will receive OPSITE, a transparent waterproof cotton pad with a high Moisture Vapour Transmission Rate. This dressing is intended to provide a protective barrier while allowing moisture vapor to escape, helping to maintain an optimal wound healing environment. The dressing will be applied post-operatively and changed according to the standardized protocol. MEPILEX POST OP BORDER MEPILEX POST OP BORDER Participants in this group will receive MEPILEX POST OP BORDER, a 4-layer foam dressing with flex technology. This advanced dressing is designed to provide superior absorption and conformability, helping to manage exudate and protect the wound site. The dressing will be applied post-operatively and changed as per the standardized protocol.
- Primary Outcome Measures
Name Time Method Incidence of Early Surgical Site Complications Day 3, Day 7, Day 14 post-surgery 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.
- Secondary Outcome Measures
Name Time Method Nurses' Ease of Application and Removal of Dressings Day 3, Day 7, Day 14 post-surgery 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.
Pain Levels During Dressing Changes Day 3, Day 7, Day 14 post-surgery 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.
Patient Satisfaction Levels Day 14 post-surgery Patient satisfaction with the dressing will be assessed using a structured questionnaire. This will be measured at day 14 post-surgery.
Patient Comfort and Mobility Day 3, Day 7, Day 14 post-surgery 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.
Trial Locations
- Locations (1)
Base Hospital Delhi cantt
🇮🇳New Delhi, India