Routine Use of Negative Pressure Wound Therapy THR TKR RCT

NCT06181097 | Recruiting DMC

• 1 other identifier: 2023.208
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Negative pressure wound therapy (NPWT) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. A prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. The number of wound complications within 21 days will be recorded. As well, the aesthetic appearance and quality of scarring of the scar will be assessed.

Conditions

Knee Arthropathy; Hip Arthropathy; Negative Pressure Wound Therapy

Keywords

Knee Arthropathy; Hip Arthropathy; TKR; THR; Wound therapy

Outcome Measures

Primary Outcomes (1)

• Wound-related complications

  Recurrence of wound exudate, surgical site infections, dressing-related issues, readmission to hospital and any further surgical interventions will be documented by the research personnel status at 21 days after the index operation.

  21 days after surgery

Secondary Outcomes (2)

• Patient Scale and Observer Scale (POSAS)

  21 days after surgery

• Multi-category visual analogue scale

  21 days after surgery

Study Arms (2)

negative pressure wound therapy

EXPERIMENTAL

Both groups will have layered closure with 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. For the NPWT group, the Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility. For the standard dressing group, the same PICO dressing will be applied, but without the suction.

Device: negative pressure wound therapy

standard dressing

ACTIVE COMPARATOR

Both groups will have layered closure with 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. For the NPWT group, the Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility. For the standard dressing group, the same PICO dressing will be applied, but without the suction.

Other: standard dressing

Interventions

negative pressure wound therapy DEVICE

The intervention group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility.

negative pressure wound therapy

standard dressing OTHER

The standard dressing group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The same PICO dressing will be applied, but without the suction.

standard dressing

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong.

You may not qualify if:

• Patients using steroid, or other immune modulators that is known to affect wound healing, prior surgery to the knee or hip, skin condition such as eczema that would result in poor healing or widen scars, patients with a known significant history of hypertrophic scarring or keloid.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Central Study Contacts

Michael Tim-Yun Ong

CONTACT

26364171; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Eligible patients will be recruited and randomized to either NPWT and standard dressing.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: December 11, 2023
• Primary Completion: December 10, 2025
• Study Completion (Estimated): December 10, 2026
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: Journal reviewers

Locations

HK (1)