Wound closure following hip arthroplasty
| ISRCTN | ISRCTN70685656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70685656 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Mr Roland Ingram
Scientific
Scientific
Glasgow Royal Infirmary
Orthopaedics Department
GateHouse Building
Castle Street
Glasgow
G4 0SF
United Kingdom
| Roland.Ingram@ggc.scot.nhs.uk |
Study information
| Study design | Multicentre three-armed randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Wound closure following hip arthroplasty: a multicentre randomised controlled trial |
| Study hypothesis | 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 |
| 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 | Other |
| Primary outcome measure | 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 at 3 months |
| Overall study start date | 05/04/2010 |
| Overall study end date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 219 in three groups |
| 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 exclusion criteria | 1. Known glue allergy 2. Coagulation disorder 3. Unable to give informed consent |
| Recruitment start date | 05/04/2010 |
| Recruitment end date | 01/04/2011 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom
G4 0SF
United Kingdom
Sponsor information
NHS Greater Glasgow and Clyde (UK)
Government
Government
R&D Management Office
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom
| Website | http://www.nhsggc.org.uk/content/ |
|---|---|
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Charity
Glasgow Royal Infirmary (UK) - Orthopaedic Endowment Fund
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
13/03/2017: No publications found, verifying study status with principal investigator.
