STASSH - TRAUMA - Absorbable vs Non-Absorbable Sutures in Trauma Hand Surgery

NCT06247761 | Unknown DMC

• 1 other identifier: 328761
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief Summary

An RCT will be set up to compare outcomes between two groups of hand surgery patients. These are:

• Emergency hand surgery patients - randomized to either absorbable or non-absorbable suture. The primary outcomes investigated will be:
• Infection occurrence The secondary outcomes will be:
• Scar appearance at 1 week and 6-8 weeks (assessed from photographs and scar scoring scale)
• Wound inflammation as a percentage of wound length at day 7 post surgery.
• Patient symptoms at 1 week (assessed from patient questionnaire)
• Patient symptoms at 6-8 weeks (assessed from patient questionnaire)
• QDASH Score at 1 week (assessed from patient questionnaire)
• QDASH score at 6-8 weeks (assessed from patient questionnaire)
• Occurrence of other complications (assessed from the above photographs, the above questionnaires and from nurse and doctor led reports of wound breakdown and other complications)

Conditions

Suture, Complication; Hand Infection; Skin Infection; Scar; Symptoms and Signs

Keywords

hand surgery; hand infection; complications; suture material; scar appearance

Outcome Measures

Primary Outcomes (1)

• Infection rate %

  Infection rate %

  6-8 weeks

Secondary Outcomes (8)

• Wound inflammation

  1 week

• Scar appearance at 1 week

  1 week

• Patient symptoms at 1 week

  1 week

• Patient symptoms at 6-8 weeks

  6-8 weeks

• Hand function at 1 week

  1 week

Study Arms (2)

Vicryl rapide suture for Skin closure

ACTIVE COMPARATOR

Skin closure at end of hand trauma surgery

Device: Skin closure at end of hand surgery

Nylon suture for Skin closure

ACTIVE COMPARATOR

Skin closure at end of hand trauma surgery

Device: Skin closure at end of hand surgery

Interventions

Skin closure at end of hand surgery DEVICE

skin closure with vicryl rapide suture

Nylon suture for Skin closure; Vicryl rapide suture for Skin closure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult emergency hand surgery patients (age 18-100) with suspected bone/tendon/nerve/blood vessel injury or high risk of infection e.g. bites

You may not qualify if:

• Patients who are unable to consent or do not consent
• Patients below the age of 18
• Patients with a known allergy to vicryl rapide (polyglactin 910) or nylon (ethilon) suture.
• Any patient whose hand surgery requires a skin graft.
• Any patient operated on as an immediate emergency e.g. amputation, revascularisation.

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• Anglia Ruskin University: collaborator

MeSH Terms

Conditions

Cellulitis; Cicatrix; Signs and Symptoms

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre, parallel, two group, randomised control trial

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 8, 2024
• Study Start: January 29, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share