Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000021673
Ethics application status
Not yet submitted
Date submitted
17/12/2013
Date registered
9/01/2014
Date last updated
7/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Total Hip joint Arthroplasty: steristrips vs skin glue for skin apposition. A randomised controlled trial.
Scientific title
A randomised controlled trial comparing steristrips and skin glue for skin apposition in patients presenting for primary total hip joint arthoplasty
Secondary ID [1] 283798 0
Nil
Universal Trial Number (UTN)
1111-1151-4912
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis requiring total hip joint replacement

 290776 0
Skin closure in total hip joint arthroplasty procedures 290850 0
Condition category
Condition code
Musculoskeletal 291139 291139 0 0
Osteoarthritis
Surgery 291213 291213 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Steristrips used to oppose the skin. Involves applying steristrips to oppose the skin edges following subcuticular closure with an absorbable barbed suture. Will take 1-2 minutes to apply. Follow up duration is at 10 days and six week marks.
Intervention code [1] 288482 0
Treatment: Surgery
Comparator / control treatment
Skin glue application to oppose skin. Skin glue applied following subcuticular closure with an absorbable barbed suture. Will take 1-2 minutes to apply. Follow up duration is at 10 day and 6 week marks.
Control group
Active

Outcomes
Primary outcome [1] 291127 0
Prolonged wound ooze.
The post operative day at which wounds stop oozing will be recorded.
The outline of wound ooze will be marked. Wounds will be
judged to have stopped oozing when there is no extension of theoutline over a 24 hour period. If the ooze is increasing and the dressing soaked the dressing will be changed. The day at which the wound is judged to stop oozing will be recorded.

If the amount of ooze is judged to be excessive and not settling a negative pressure dressing will be applied. dressing of choice at our institution.
Timepoint [1] 291127 0
Monitored on a daily basis during the post operative stay.
Primary outcome [2] 291128 0
Need for negative pressure wound dressing (PICO dressing) application for prolonged wound ooze.

***PICO is the brand name of the dressing****

Binary outcome. The need to apply a PICO dressing is a subjective decision, PICOs will be applied to wounds that are deemed to be peristently oozy. They will not be applied in the first 4 days post operatively.
Timepoint [2] 291128 0
Monitored on a daily basis during inpatient stay.
Primary outcome [3] 291129 0
Antibiotic administration for wound erythema/infection.
Review of the patients medical records, and patients will be asked about this retrospectively at 10 day and 6 week folow ups. results will be recorded.
Timepoint [3] 291129 0
monitored on a daily basis for duration of hospital stay; assessed at 10 day and 6 week follow ups.
Secondary outcome [1] 306093 0
Return to theatre for washout of wound.
review of patients medical records.
Timepoint [1] 306093 0
monitored on a daily basis for duration of hospital stay, followed up at 10 day and 6 week marks.
Secondary outcome [2] 306094 0
Deep hip infection involving the joint cavity.
review of patients medical records.
Timepoint [2] 306094 0
monitored on a daily basis for duration of hospital stay. reviewed at 10 days and 6 weeks post surgery. Not only are
deep infections rare revents, they usually take longer to develop/declare themselves, we do not expect any cases of deep infection in this study.

Eligibility
Key inclusion criteria
Persons presenting for primary total hip joint replacement to Hutt Valley Hospital/Boulcott hospital, between February 2014-October 2014. (under the care of the Consultants prepared to be involved in the trial)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Revision hip surgery. Previous history of allergy to steristrips/skin glue.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be invited to participate at pre-assessment clinic by the orthopaedic pre-assessment nurse or at Consultant clinic at the time of booking for THJR (total Hip Joint Replacement). Patients will be randomly allocated to one of two groups: steristrips to oppose the skin edges group or to the skin glue group (ie: a two armed study). Randomisation will occur via opaque envelopes using a sequence that has been generated by a computer random number generator. Allocation to either group will occur in the operating theatre after closure of the deep and superficial layers. Once randomised all patients will remain in the group to which they are allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated random sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study has been designed aiming for a minimum power of 80% for the primary outcome. The power calculations are based on statistics from previous studies, which have suggested prevalence in the general population of the measured outcomes. A sample size of 180. Outcomes between groups will be compared using a paired-t test, with 95% confidence intervals.
1) Wound ooze duration:
Wood et al (2007) looked at wound ooze length after hip replacement: median time for wounds to be dry 4 days (interquartile range 3-6days). (n=62). A one day variance in our study would be clinically significant as for each day the wound continues to ooze hospital admission is prolonged.
Sample size
If we assume log-normal distribution then the median and interquartile range on the log scale (base e) are, 1.386 (1.099 – 1.792) and the interquartile range covers 1.349 SD giving SD=0.514, a difference of 1 day, from a geometric mean of 4 days to 3 days.
A sample size 90 in each group has 90% power to find a difference of 1 day between 4.5 and 3.5, based on the study of Wood et al (2007) that found the median time for wounds to be dry 4 days (interquartile range 3-6 days) and assuming a log-normal distribution.
2) Need for PICO dressing for persistent wound ooze
O’smith et al (2010) meta-analysis found prolonged wound discharge after hip replacement in 2/64 closed with sutures, 3.1% (95%CI 0.4% – 10.8%). With 90 in each group the trial will have 80% power to find differences between, say, 0.5% and 11.5% significant

3) Antibiotic administration for wound erythema/superficial infection.
The rate of infection between the two methods is poorly publicized.
Paediatic study Wilson et al looking at unilateral cleft palate repair, suggested rates of post op infection 4% with steristrips Vs 0% for dermabond. (numbers 121 steristrip, 186 in dermabond).
0% (95%CI 0%–2.0%) (0/186) for skin glue and 4% (95%CI 1.4%–9.4%) (5/121) for steristrip. With 90 in each group the trial will have 80% power to find differences between, say, 0.1% and 10.5% significant.
4) Return to theatre for wound washout.
I was unable to identify rates of hip wounds requiring washout in the literature. Anecdotally though this is not overly common. Would be an important outcome to record but unlikely to find a statistically significant difference between the two groups.
5) Deep infection involving the joint
Deep infection occurs in 0.2-0.6%. Unlikely to have any of these in this study, and usually occur late (outside the follow up period). However, this is still an important, albeit rare outcome to document.
References
Wood J, Bevis, P, and Bannister, G (2007). Wound oozing after total hip arthroplasty. Annals of the Royal College of Surgeons of England, 89(2), 140.
O’Smith T, Sexton D, Mann C, Donell S. Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. BMJ. 2010; 340: c119doi:10.1136/bmj.c1199.
Wilson, Andrew DH, and Nigel Mercer. "DermabondTM Tissue Adhesive Versus Steri-StripsTM in Unilateral Cleft Lip Repair: An Audit of Infection and Hypertrophic Scar Rates." The Cleft Palate-Craniofacial Journal 45.6 (2008): 614-619.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2014
Actual
Date of last participant enrolment
Anticipated
1/02/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 5691 0
New Zealand
State/province [1] 5691 0
Hutt Valley

Funding & Sponsors
Funding source category [1] 288458 0
Self funded/Unfunded
Name [1] 288458 0
Country [1] 288458 0
Primary sponsor type
Hospital
Name
Hutt Valley District Health Board
Address
High Street,
Lower Hutt,
Wellington
New Zealand
5040
Private Bag 31907
Country
New Zealand
Secondary sponsor category [1] 287161 0
Hospital
Name [1] 287161 0
Boulcott Hospital
Address [1] 287161 0
666 High Street,
Lower Hutt,
Wellington
5051
Country [1] 287161 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290327 0
Health and Disability Ethics Commitee
Ethics committee address [1] 290327 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 290327 0
New Zealand
Date submitted for ethics approval [1] 290327 0
25/04/2014
Approval date [1] 290327 0
Ethics approval number [1] 290327 0

Summary
Brief summary
The aim the of the study is to determine if skin wounds opposed with skin glue results in fewer wound complications compared with wounds opposed with steristrips in hip replacement surgery. It is hypothesised that wounds closed with skin glue will result in relatively fewer wound complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45102 0
Dr Liam Dunbar
Address 45102 0
Cardiothoracic Registrar at Wellington Hospital. 57b Broadmeadows Wellington New Zealand 6035
Country 45102 0
New Zealand
Phone 45102 0
+64274914490
Fax 45102 0
Email 45102 0
[email protected]
Contact person for public queries
Name 45103 0
Dr Liam Dunbar
Address 45103 0
Cardiothoracic Registrar at Wellington Hospital. 57b Broadmeadows Wellington New Zealand 6035
Country 45103 0
New Zealand
Phone 45103 0
+64274914490
Fax 45103 0
Email 45103 0
[email protected]
Contact person for scientific queries
Name 45104 0
Dr Liam Dunbar
Address 45104 0
Cardiothoracic Registrar at Wellington Hospital. 57b Broadmeadows Wellington New Zealand 6035
Country 45104 0
New Zealand
Phone 45104 0
+64274914490
Fax 45104 0
Email 45104 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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