None listed
Conditions
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.
Interventions
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 CLIN
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.
Sponsors
A/Prof (Hon) Jon Mathy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
History of allergy to FLUCLOXACILLIN or CLINDAMYCIN. Pre-operative administration of antibiotics. Inability to return for follow up. Inability to consent independently.
Outcome results
None listed