Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540040
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Fishers exact test for cells with expected values less than 5
A p-value of less than 005 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
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 Fishers exact test for cells with expected values less than 5
A p-value of less than 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None