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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06181097
Other study ID # 2023.208
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 11, 2023
Est. completion date December 10, 2026

Study information

Verified date December 2023
Source Chinese University of Hong Kong
Contact Michael Tim-Yun Ong
Phone 26364171
Email michael.ong@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 82
Est. completion date December 10, 2026
Est. primary completion date December 10, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong. Exclusion Criteria: - 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.

Study Design


Intervention

Device:
negative pressure wound therapy
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.
Other:
standard dressing
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.

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Patient Scale and Observer Scale (POSAS) The POSAS has category boxes to core nominal parameters, for example colour of the scar. Each item of both scales have a 10-point score, with 10 indicating the worse imaginable scar or sensation and 1 corresponding to normal scar or skin (normal pigmentation, no itching, etc.). The total score of both scale is calculated by summing up the score of each of the six items and ranges from 6 to 60. 21 days after surgery
Secondary Multi-category visual analogue scale The multi-category visual analogue scale (VAS) is a photograph based scale derived from evaluating standardised digital photographs in four categories (pigmentation, vascularity, acceptability and patient comfort) plus contour. The individual scores are added to give a single overall score ranging from "excellent" to "poor" 21 days after surgery
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