Wound closure following hip arthroplasty

ISRCTN	ISRCTN70685656
DOI	https://doi.org/10.1186/ISRCTN70685656
Protocol serial number	N/A
Sponsor	NHS Greater Glasgow and Clyde (UK)
Funder	Glasgow Royal Infirmary (UK) - Orthopaedic Endowment Fund

Submission date: 25/01/2010
Registration date: 05/02/2010
Last edited: 13/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
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 Roland Ingram
Scientific

Glasgow Royal Infirmary
Orthopaedics Department
GateHouse Building
Castle Street
Glasgow
G4 0SF
United Kingdom

Email	Roland.Ingram@ggc.scot.nhs.uk

Study information

Primary study design	Interventional
Study design	Multicentre three-armed randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Wound closure following hip arthroplasty: a multicentre randomised controlled trial
Study objectives	Closing wounds, after total hip replacement, with DERMABOND® (skin glue) in addition to sutures will significantly decrease wound leakage and consequently surgical site infection rates.
Ethics approval(s)	West of Scotland Research Ethics Committee - pending approval as of 25/01/2010
Health condition(s) or problem(s) studied	Post-operative wound leakage and surgical site infection
Intervention	All subjects in each of three randomised groups will have total hip arthroplasty wounds closed in layers with absorbable sutures. Subcuticular skin closure will be performed using monofilament suture (3/0 Biosyn) to oppose the wound edges. Each group will differ in the method of wound dressing. Group 1: A standard absorbent dressing will be applied to the wound. Group 2: DERMABOND® tissue adhesive will be applied to the dry wound in multiple thin layers. The width of the application will be approximately 5 mm either side of the incision. DERMABOND® will only be applied topically and never between wound edges. A standard absorbent dressing will be applied to the wound. Group 3: DERMABOND® tissue adhesive will be applied to the dry wound in multiple thin layers as for Group 2. A standard large Tegaderm™ dressing will then be applied to the wound. The wound will be dressed for several weeks post-operatively but this will vary from patient to patient. Follow-up will be 3 months.
Intervention type	Other
Primary outcome measure(s)	Wound leakage at 3 days post-operative
Key secondary outcome measure(s)	1. Wound complications including infection, assessed daily until patient is discharged and followed up at 3 months, and discharge, assessed daily until patient is discharged from hospital. Any discharge beyond day 4 will be classified as prolonged 2. Time to discharge 3. Cosmetic appearance, measured using a modified Hollander Scale to assess cosmesis at 3 months post-operatively 4. Pain, measured using a visual analogue scale to assess pain daily until discharge and at 3 months
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	219
Key inclusion criteria	1. Anyone requiring elective Total Hip Replacement at Glasgow Royal Infirmary or Royal Alexandra Hospital (Paisley) 2. Able to give informed consent 3. Aged over 18 years, either sex
Key exclusion criteria	1. Known glue allergy 2. Coagulation disorder 3. Unable to give informed consent
Date of first enrolment	05/04/2010
Date of final enrolment	01/04/2011

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Glasgow Royal Infirmary

Glasgow
G4 0SF
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

13/03/2017: No publications found, verifying study status with principal investigator.