A randomized trial comparing Octyl-cyanoacrylate and subcuticular sutures for post-auricular wound cosmesis

ISRCTN	ISRCTN96030942
DOI	https://doi.org/10.1186/ISRCTN96030942
Protocol serial number	N0227186102
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	South Tees Hospitals NHS Trust (UK)

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 27/10/2015

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr A Banerjee
Scientific

South Tees NHS Hospitals Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomized trial comparing Octyl-cyanoacrylate and subcuticular sutures for post-auricular wound cosmesis
Study objectives	Is there a difference in the cosmetic appearance of post-auricular wounds closed using Octyl-cyanoacrylate or subcuticular sutures at 3 months, as judged by a visual analogue scale assessment of photographs by assessors blinded to treatment allocation?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Ear
Intervention	Patients will be given the Patient Information Leaflet and informed consent will be obtained on enrolment, this will take place at the time of being listed for surgery. Demographic details will be listed on the Wound Evaluation Proforma at the time of enrolment and include age, sex, and hospital number. Patients will be randomized, using a random numbers table, to one of two methods of skin closure, subcuticular 4-0 vicryl sutures or octyl-cyanoacrylate (Dermabond). The operating surgeons will be given instruction on using octyl-cyanoacrylate by the Dermabond Representative. The operating surgeon will not be aware of which arm of the study the patients will be assigned to at the time of consenting the patient. The post-auricular wounds will be closed by ENT surgeons operating at a single teaching hospital. The time taken to close the skin will be measured in seconds from the time of picking up to laying down of the surgical instruments, and this will be recorded on the wound evaluation proforma to the nearest tenth of a second. A single intra-operative dose of intravenous Co-amoxiclav 1.2g will be given to all patients, unless they are penicillin allergic in which case Clarithromycin 500mg will be used. A head bandage will be applied in theatre on completion of the procedure and will be removed the following day. Patients will be discharged from hospital on the first post-operative day. All patients will be followed-up in the ENT clinic at 3 weeks post-operatively for removal of dressings from the external auditory canal as per current practice. At this point the clinician will record on the Wound Evaluation Proforma: any history or signs of wound infection, wound dehiscence or antibiotics prescribed post-operatively. All patients will be followed-up again in the ENT clinic at 3 months post-operatively as per current practice. At this point 1 standard photo will be taken of the wound., and the wound will be assessed by the principal investigator using the validated Hollander Wound Evaluation Scale (HWES), which assesses 6 clinical variables: step-off borders, contour irregularities, scar width, edge inversion, excessive inflammation and overall cosmesis. Each category is assigned a score of 1 or 0. A score of 0 is considered optimal, a score of 1-6 suboptimal. This will be recorded on the Wound Evaluation Proforma. During the evaluation and photography the assessor will be blinded to the method of skin closure used. Other clinical variables that will also be recorded on completion of the HWES will include the specific procedure the patient has undergone, the method of skin closure, whether the patient has worn glasses post-operatively, and whether they are a smoker. The data collection is expected to be complete approximately 9 months later, in January 2007. The photos of the wounds will then be compiled and judged by 2 independent surgeons who have an interest in facial surgery and blinded to treatment allocation. A validated cosmesis visual analogue scale will be used, comprising of a 100mm line with 'worst scar' on the left end and 'best scar' at the right end. A mark placed along the line is measured in millimetres from the left margin, and this constitutes the score. The higher the score the better the cosmesis.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Octyl-cyanoacrylate
Primary outcome measure(s)	Cosmetic appearance of post-auricular wounds as judged by a visual analogue scale assessment of photographs by assessors blinded to treatment allocation.
Key secondary outcome measure(s)	1. Time taken for skin closure (seconds) 2. Early wound complication (infection, dehiscence) assessed at 3 weeks 3. Cosmetic appearance of post-auricular wounds as judged by the Hollander Wound Evaluation Scale assessed at 3 months
Completion date	28/02/2007

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	All
Target sample size at registration	140
Key inclusion criteria	This sample aims to have 80% power to detect a statistically significant difference between groups with 95% confidence if the true difference between treatment outcomes is at least 0.5 of a standardised difference (ie approximately 8mm on the visual analogue scale). This will require 125 patients in the final analysis. We aim to recruit 140 patients to allow for 10% loss to follow-up. Support was provided by Dr Bellamy in calculating the sample size. Inclusion criteria will be adult and paediatric patients undergoing ear surgery using a post-auricular incision.
Key exclusion criteria	Revision surgery, acute mastoiditis, diabetes mellitus, coagulopathy, personal or family history of keloid or hypertrophic scar formation, reopening of the wound eg for drainage of wound haematoma, allergy to skin glue.
Date of first enrolment	01/04/2006
Date of final enrolment	28/02/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

South Tees NHS Hospitals Trust

Middlesbrough
TS4 3BW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/10/2015: no publications found on PubMed.