Facial lacerations in patients with facial trauma Injury, Occupational Diseases, Poisoning Open wound of other parts of head, facial laceration, facial trauma
Conditions
Interventions
This study is a single centre, single-blinded randomised controlled trial with 2 treatment arms:
1. Resorbable (Vicryl Rapide)
2. Non-resorbable sutures (Ethilon).
The trial will recruit participan
these details will need to be relayed to the designated independent clinician through email for entry into the secure database.
Patients, relatives and treating physicians cannot be blinded due to th
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Complication rate measured using a review of medical notes at 6 months 2. Patient-reported outcome measured using a telephone interview to discuss overall satisfaction of care at 6 months 3. Cost-benefit analysis measured using a review of medical notes at 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed