Can we test antimicrobial stitches in surgery for hand and wrist injuries? A feasibility study

Not Applicable

Completed

• Conditions: Complications of surgical care following injuries to the wrist and hand; Surgery

• Registration Number: ISRCTN10771059
• Lead Sponsor: niversity of Oxford

Brief Summary

2022 Protocol article in https://doi.org/10.1302/2633-1462.37.BJO-2022-0048 (added 14/07/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37758504/ (added 28/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-10
• Study Completion: 2023-06-30
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Adults aged 18 years and above undergoing hand and wrist trauma surgery requiring sutures and able and willing to provide informed consent.

Exclusion Criteria

1. Allergic to triclosan (active coating in antimicrobial sutures).
2. Infected wounds.
3. Wounds not amenable to skin closure with sutures.
4. Nailbed injuries.
5. Unable to complete study procedures, including the completion of a patient questionnaire in English.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured using patient records at the end of the study:<br> 1. Number of eligible patients that are randomised to either the intervention or control<br> 2. Number of eligible patients<br> 3. Number of patients that consent to be included in the study<br> 4. Number of participants with completed outcome measures<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Surgical site infection (SSI) measured using the Bluebelle Wound Healing Questionnaire (WHQ) at 30 days and 90 days post- surgery<br> 2. Hand function measured using the Patient Evaluation Measure (PEM) Part 2 and PROMIS Upper Extremity (PROMIS UE) at 30 days, 90 days and 6 months post-surgery<br> 3. Health-related quality of life (HRQoL)measured using the EQ-5D-5L at 30 days, 90 days and 6 months post-surgery<br> 4. Return to work measured using a return to work questionnaire 90 days and 6 months post- surgery<br>