Clinical trial NCT06540040: Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopaedics Wound Dressings
Keywords: wound healing
surgical wound infection
Randomised Controlled Tmrial
Patient comfort
Pain management
Lead sponsor: Base Hospital Delhi Cantt
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ### Model Description

\*\*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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Early Surgical Site Complications
timeFrame: Day 3, Day 7, Day 14 post-surgery
Secondary outcomes:
measure: Pain Levels During Dressing Changes
timeFrame: Day 3, Day 7, Day 14 post-surgery
measure: Patient Comfort and Mobility
timeFrame: Day 3, Day 7, Day 14 post-surgery
measure: Nurses' Ease of Application and Removal of Dressings
timeFrame: Day 3, Day 7, Day 14 post-surgery
measure: Patient Satisfaction Levels
timeFrame: Day 14 post-surgery
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Base Hospital Delhi cantt
Study officials:
affiliation: Base Hospital Delhi Cantt
name: Amresh Ghai, MS (Ortho)
role: STUDY_DIRECTOR
References: