Comparative Efficacy of Advanced and Traditional Wound Dressings in Post-Operative Orthopedic Care

NCT06540040 | Completed FDA Device

• 1 other identifier: 88/2022
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopaedics Wound Dressings

Keywords

wound healing; surgical wound infection; Randomised Controlled Tmrial; Patient comfort; Pain management

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 3, Day 7, Day 14 post-surgery

Secondary Outcomes (4)

• Pain Levels During Dressing Changes

  Day 3, Day 7, Day 14 post-surgery

• Patient Comfort and Mobility

  Day 3, Day 7, Day 14 post-surgery

• Nurses' Ease of Application and Removal of Dressings

  Day 3, Day 7, Day 14 post-surgery

• Patient Satisfaction Levels

  Day 14 post-surgery

Study Arms (4)

Aquacel Ag

EXPERIMENTAL

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.

Device: Aquacel Ag

OPSITE

EXPERIMENTAL

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.

Device: OPSITE

MEPILEX POST OP BORDER

EXPERIMENTAL

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.

Device: MEPILEX POST OP BORDER

Traditional Dressing

ACTIVE COMPARATOR

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.

Device: Traditional Dressing

Interventions

Aquacel Ag DEVICE

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.

Also known as: Hydrofibre wound dressing with ionic silver

Aquacel Ag

OPSITE DEVICE

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.

Also known as: Transparent waterproof cotton pad

OPSITE

MEPILEX POST OP BORDER DEVICE

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.

Also known as: 4-layer foam dressing with flex technology

MEPILEX POST OP BORDER

Traditional Dressing DEVICE

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.

Also known as: Gauze pieces, surgical pads, and porous paper adhesive strips

Traditional Dressing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nidhi Srivastava: lead

Study Sites (1)

Base Hospital Delhi cantt

New Delhi, 110010, India

Location

Related Publications (1)

• 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.

  PMID: 40070522 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection; Agnosia

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Amresh Ghai, MS (Ortho)

  Base Hospital Delhi Cantt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: his study is an open-label trial, meaning that there is no masking. All parties involved in the study, including participants, care providers, investigators, and outcome assessors, are aware of the type of dressing each participant receives.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ortho Matron

Model Details: \### 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.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: August 10, 2022
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2022
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)