Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care
NCT ID: NCT06540040
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2022-08-10
2022-12-10
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
\*\*Parallel Assignment\*\*: This study employs a parallel assignment model, where participants are randomly allocated to one of four intervention groups. Each group receives a distinct type of wound dressing post-operatively. The outcomes are measured and compared across these groups to evaluate the efficacy of each dressing type. The interventions include Aquacel Ag, OPSITE, MEPILEX POST OP BORDER, and traditional gauze-based dressings. This model allows for a direct comparison of the different interventions in a controlled manner.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Aquacel Ag
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
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.
OPSITE
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
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.
MEPILEX POST OP BORDER
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.
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.
Traditional Dressing
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.
Interventions
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Aquacel Ag
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
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
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.
Traditional Dressing
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Nidhi Srivastava
OTHER
Responsible Party
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Nidhi Srivastava
Ortho Matron
Principal Investigators
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Amresh Ghai, MS (Ortho)
Role: STUDY_DIRECTOR
Base Hospital Delhi Cantt
Locations
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Base Hospital Delhi cantt
New Delhi, , India
Countries
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References
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Srivastava N, Manisha, Ghai A, Goyal M, Kumar M, Kumar M. Comparative efficacy of advanced and traditional wound dressings in post-operative orthopaedic care for hip and knee surgeries: A randomized controlled trial. J Clin Orthop Trauma. 2025 Feb 12;63:102933. doi: 10.1016/j.jcot.2025.102933. eCollection 2025 Apr.
Other Identifiers
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88/2022
Identifier Type: -
Identifier Source: org_study_id
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