Condition category
Surgery
Date applied
25/01/2010
Date assigned
05/02/2010
Last edited
30/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Roland Ingram

ORCID ID

Contact details

Glasgow Royal Infirmary
Orthopaedics Department
GateHouse Building
Castle Street
Glasgow
G4 0SF
United Kingdom
Roland.Ingram@ggc.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Wound closure following hip arthroplasty: a multicentre randomised controlled trial

Acronym

Study hypothesis

We hypothesise that 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

West of Scotland Research Ethics Committee pending approval as of 25/01/2010

Study design

Multicentre three-armed randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Drug

Phase

Not Applicable

Drug names

DERMABOND®

Primary outcome measures

Wound leakage at 3 days post-operative.

Secondary outcome measures

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 again at 3 months

Overall trial start date

05/04/2010

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

219 in three groups

Participant exclusion criteria

1. Anyone with known glue allergy
2. Anyone with a coagulation disorder
3. Anyone unable to give informed consent

Recruitment start date

05/04/2010

Recruitment end date

01/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

R&D Management Office
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom

Sponsor type

Government

Website

http://www.nhsggc.org.uk/content/

Funders

Funder type

Charity

Funder name

Glasgow Royal Infirmary (UK) - Orthopaedic Endowment Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes