Dissolvable versus non-dissolvable stitches for traumatic cuts of the face

Not Applicable

Completed

• Conditions: Facial lacerations in patients with facial trauma; Injury, Occupational Diseases, Poisoning; Open wound of other parts of head, facial laceration, facial trauma

• Registration Number: ISRCTN55795740
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-16
• Study Completion: 2023-08-27
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Willing and able to give informed consent for participation in the trial
2. Aged =18 years
3. Diagnosed with a traumatic laceration affecting the facial region

Exclusion Criteria

1. Wounds with the following characteristics:
1.1. Significant contamination or presenting later than 12 h after the initial injury
1.2. Animal or human bites
1.3. Wounds requiring antibiotic prophylaxis
1.4. Wounds amenable to closure with adhesive tape or tissue adhesive
1.5. Complex lacerations requiring closure under general anaesthetic
1.6. Not amenable to primary closure (significant tissue loss requiring more complex closure methods)
1.7. Lacerations involving cartilage or bony injuries
1.8. Injuries involving parotid gland, parotid duct, or facial nerve
1.9. Wounds requiring smaller than 5/0 suture material
2. Scalp lacerations due to difficulties in assessing the cosmetic outcome
3. Presence of accompanying injury/polytrauma requiring more extensive medical/surgical intervention as a priority
4. History of:
4.1. History of keloid or hypertrophic scar formation
4.2. Collagen vascular disorders
4.3. Prolonged corticosteroid use
4.4. Type I diabetes or poorly controlled type II diabetes
4.5. Primary or secondary immunodeficiency (including systemic chemotherapy)
4.6. Clotting or bleeding disorders
4.7. Allergy to chloramphenicol 1% ointment
4.8. Recent radiotherapy to the head and neck
5. Unable to give written informed consent, including patients considered under the influence of alcohol (or recreational/medicinal substances) at the time of patient consultation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cosmetic outcome measured using a visual analogue cosmesis scale (VAS) to assess cosmetic results from patient images sent in for their electronic medical records at 6 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Complication rate measured using a review of medical notes at 6 months<br> 2. Patient-reported outcome measured using a telephone interview to discuss overall satisfaction of care at 6 months<br> 3. Cost-benefit analysis measured using a review of medical notes at 6 months<br>