ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000364471

Ethics application status

Approved

Date submitted

15/03/2016

Date registered

21/03/2016

Date last updated

23/05/2022

Date data sharing statement initially provided

21/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

PICASSO: Prophylactic IncCsional Antibiotics in Skin Surgery trial. Can infiltrating antibiotics reduce the rate of wound infection?

Scientific title

Efficacy of incisional antibiotics to reduce wound infection and graft failure following excision of skin lesions

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1171-0431

Trial acronym

PICASSO
Prophylactic InCisional Antibiotics in Skin cancer Surgery

Linked study record

Health condition

Health condition(s) or problem(s) studied:

wound infection

graft failure

Condition category

Condition code

Surgery

Surgical techniques

Cancer

Non melanoma skin cancer

Cancer

Malignant melanoma

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention

Arm 1: 1% LIDOCAINE plus ADRENALINE 1:100,000 buffered 1:10 with 8.4% sodium bicarbonate (50 mEq/50mL) plus FLUCLOXACILLIN 500 micrograms/mL delivered by injection into subcutaneous tissue as a field block immediately prior to skin excision as a single dose. The volume injected will vary between skin lesions according to amount deemed necessary by the operating surgeon.

Arm 2: 1% LIDOCAINE plus ADRENALINE 1:100,000 buffered 1:10 with 8.4% sodium bicarbonate (50 mEq/50mL) plus CLINDAMYCIN 408 micrograms/mL delivered by injection into subcutaneous tissue as a field block immediately prior to skin excision as a single dose. The volume injected will vary between skin lesions according to amount deemed necessary by the operating surgeon.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Control

1% LIDOCAINE plus ADRENALINE 1:100,000 buffered 1:10 with 8.4% sodium bicarbonate (50 mEq/50mL) delivered by injection into subcutaneous tissue as a field block immediately prior to skin excision as a single dose. The volume injected will vary between skin lesions according to amount deemed necessary by the operating surgeon.

Control group

Placebo

Outcomes

Primary outcome [1]

Wound infection: all surgical sites will be assessed at 5-10 days and 3-4 week time points postoperatively and graded for signs of infection as per the standardized scoring system adopted from Griego et al.
Griego R, Zitelli J. Intra-incisional prophylactic antibiotics for dermatologic surgery. Archives of Dermatology. 1998;134(6):688-92.

Timepoint [1]

Once at 5 days post surgery and once at 3 weeks post surgery.

Secondary outcome [1]

Graft take: all surgical sites closed with a skin graft will be assessed at 5-10 days and 3-4 week time points postoperatively and graded for percentage graft take. A transparent plastic film with a printed grid 1cm x 1cm will be used to estimate the total size of the graft and the percentage of graft take. Photographs will be taken for re-assessment by another observer.

Timepoint [1]

Once at 5 days post surgery and once at 3 weeks post surgery.

Eligibility

Key inclusion criteria

All patients waitlisted for surgical management of skin lesions following specialist evaluation at the CMDHB Skin Cancer Centre and whom are able to provide consent independently.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

History of allergy to FLUCLOXACILLIN or CLINDAMYCIN.
Pre-operative administration of antibiotics.
Inability to return for follow up.
Inability to consent independently.

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 treated with de-identified injectable solutions with a unique code. The allocation to a particular group will only be known in hindsight to the study overseer.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomization of patient de-identified injectable will be assigned using random block sizes, stratified according to location of the surgical site (any site on a lower extremity vs. no site on a lower extremity), and will be delivered via opaque envelopes prepared by study statistician preoperatively.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

To account for the testing of two primary hypotheses, we apply a False Discovery Rate correction (equivalent in this case to a Bonferroni correction) to the nominal 5% significance level against two-sided hypotheses under which statistical inference will be effected in the intended full study. We further posit two reasonable values for expected infection rates under the hypothesis of a beneficial treatment effect, namely reductions from a 7% POWI rate to 3.5% and 2% respectively. We determine the expected study sizes required to achieve 80% power under these two scenarios: 2340 and 987 respectively.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

18/02/2019

Actual

18/02/2019

Date of last participant enrolment

Anticipated

31/07/2019

Actual

4/12/2019

Date of last data collection

Anticipated

1/12/2020

Actual

1/12/2020

Sample size

Target

2340

Accrual to date

Final

2340

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

New Zealand Health Research Council

Address [1]

Physical Address: Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street (GPS: 50 Grafton Road), Grafton, Auckland 1010
Postal Address: PO Box 5541, Wellesley Street, Auckland 1141
Phone: 09 303 5200
Email: info@hrc.govt.nz

Country [1]

New Zealand

Primary sponsor type

Individual

Name

A/Prof (Hon) Jon Mathy

Address

Plastic, Reconstruction & Hand Department
Middlemore Hospital
100 Hospital Road
Auckland
2025

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington
New Zealand 
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

30/11/2015

Approval date [1]

14/03/2016

Ethics approval number [1]

15/CEN/260

Summary

Brief summary

Delayed healing and graft failure secondary to infection contribute to morbidity amongst patients undergoing excision of melanoma and non-melanoma skin cancers. Infection delays healing and leads to more prominent scar formation while graft failure also delays healing and may necessitate further surgery or lead to chronic wounds. Such complications have a flow on effect economically as further nursing resources are occupied, dressings are required for longer and in younger patients a return to work may be delayed.  The adjusted infection rate amongst patients undergoing excision of skin lesions through the Plastic, Reconstructing & Hands department at Middlemore Hospital is approximately 7%.
Studies have previously demonstrated that pre-operative infiltration of antibiotic to the incision site simultaneously with local anaesthetic leads to a reduction in post-operative wound infections1, 2. However, these studies have been performed in private Mohs micrographic surgery centres and the process has yet to be applied in a public setting. To our knowledge, the process has not been tested in patients requiring split thickness and full thickness skin grafts following excision of melanoma and non-melanoma skin cancers.
The approaching calamity of antibiotic resistance adds further impetus to the judicious use of antibiotics. Many surgeons routinely prescribe pre-operative antibiotics and/or a course of antibiotics post-operatively in an attempt to reduce morbidity. Not only does this systemic approach contribute to the evolution of antibiotic resistance but it certainly confers morbidity in terms of antibiotic side effects to some patients. Here we seek to apply the principle of intra-incisional antibiotics in a high volume public care setting to determine whether this more judicious use of antibiotics can reduce post-operative wound infection and graft failure secondary to infection.

Trial website

nil

Trial related presentations / publications

nil

Public notes

nil

Contacts

Principal investigator

Name

Mr Jon Mathy

Address

Department of Plastic, Reconstructive and Hand Surgery
100 Hospital Road
Middlemore Hospital
Auckland
2025

Country

New Zealand

Phone

+64 9 276 0000

Fax

jonathan.mathy@middlemore.co.nz

Contact person for public queries

Name

Jon Mathy

Address

Department of Plastic, Reconstructive and Hand Surgery
100 Hospital Road
Middlemore Hospital
Auckland
2025

Country

New Zealand

Phone

+64 9 276 0000

Fax

jonathan.mathy@middlemore.co.nz

Contact person for scientific queries

Name

Jon Mathy

Address

Department of Plastic, Reconstructive and Hand Surgery
100 Hospital Road
Middlemore Hospital
Auckland
2025

Country

New Zealand

Phone

+64 9 276 0000

Fax

jonathan.mathy@middlemore.co.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

individual data will not be released to respect patient confidentiality

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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