Comparison of the Effect of Intravenous Versus Intraincisional Antibiotics on Surgical Site Infection and Related Complications in Patients with Head and Neck Skin Cancer : A Randomized Controlled Trial (RCT)

To evaluate the effect of intravenous antibiotic prophylaxis versus intra incisional antibiotic prophylaxis on reducing SSIs and their related complications in patients with head and neck skin cancer undergoing surgery . To compare local and systemic adverse effects in patients receiving intra-incisional prophylactic antibiotics with those receiving intravenous prophylactic antibiotics.

A randomized, single-blind, parallel-group clinical trial conducted on 42 patients.

A randomized controlled clinical trial conducted to evaluate and compare the effect of intravenous antibiotic prophylaxis versus intra-incisional antibiotic prophylaxis on reducing surgical site infections and related complications in patients with head and neck skin cancer. Patients with head and neck skin cancer who are admitted for surgical treatment at Farhikhtegan Hospital, Tehran.

Inclusion criteria : Patients with head and neck skin cancer who are candidates for surgical treatment. Written informed consent to participate in the study. No history of allergy to the antibiotics used in the study. Exclusion criteria : Patients with systemic diseases that affect wound healing (uncontrolled diabetes).Patients with immunodeficiency.Patients who do not adhere to the prescribed treatment.

Group 1 : A dose of intravenous antibiotic one hour before surgery, as the standard prophylactic protocol. Group 2 : The antibiotic locally at the surgical incision site during the operation as an intra-incisional prophylactic dose.

Incidence of SSI; Severity of complications; Length of hospital stay; Need for additional antibiotic therapy.

In this randomized clinical trial, eligible patients who provide written informed consent will be randomly assigned in a 1:1 ratio to one of two groups: preoperative intravenous antibiotic and intra-incisional antibiotic administered during surgery. The random allocation sequence will be generated by a biostatistician using a computer-based random number generator and block randomization with blocks of size 4, in order to ensure a balanced distribution of patients between the two groups. For allocation concealment, the allocation code for each patient will be placed, according to the randomization list, in sequentially numbered, opaque, sealed envelopes that are impermeable to light. After a patient is enrolled in the study, the investigator responsible for recruitment will open the next envelope in sequence and assign the patient to the corresponding intervention group (intravenous or intra-incisional antibiotic). The biostatistician responsible for data analysis will remain blinded to the group allocation.

Due to the nature of the intervention (intravenous antibiotic one hour before surgery versus intra incisional antibiotic during surgery), blinding of the surgeon and anesthetic team is not feasible and the intervention is open to the care providers. However, to reduce bias, all patients will be recorded in the database with anonymous group codes (Group A and Group B), and the statistician/data analyst will be blinded to the allocation when performing the final analysis (single-blind trial – data analyst). If feasible, assessment of surgical site infection during follow-up visits will be performed by an outcome assessor who is unaware of the patient’s allocation.

Identified individual participant data, including demographic and clinical information, data related to the therapeutic intervention, wound status, postoperative complications, and occurrence of surgical site infection within 30 days after surgery. These data may be shared after removal of patients’ identifying information and with respect for confidentiality, upon reasonable request by researchers and approval of the principal investigator.

The access period for de-identified data and study documents will begin 6 months after publication of the final study results and will continue for 2 years. Access to the data will be subject to a reasonable request, approval by the principal investigator, and compliance with confidentiality principles.

Researchers and faculty members affiliated with universities, research centers, and accredited scientific institutions may submit requests to access the de-identified data and study documents. Access will be granted after review of the research purpose, approval by the principal investigator, and commitment to confidentiality principles and use of the data solely for scientific and research purposes.

The de-identified data and study documents may be used only for scientific, research, and educational purposes, systematic reviews, meta-analyses, and secondary analyses related to the study topic. Use of the data for commercial or advertising purposes, re-identification of participants, or disclosure of individual patient information is not permitted. Requirements for submitting a data access request include a written request, a clear statement of the research objective, submission of a proposal or data analysis plan, specification of the required data, commitment to confidentiality, agreement not to attempt re-identification of participants, use of the data only within the approved purpose, and approval by the principal investigator.

Applicants requesting access to de-identified data or study documents may primarily submit their request by email to the principal investigator of the study. The request should include the applicant’s introduction, institutional affiliation, research objective, type of data or documents requested, and data analysis plan. If needed, correspondence through the postal address of the relevant department or research center at Farhikhtegan Hospital, Tehran, will also be possible.

The applicant should submit a written request to the principal investigator, including an institutional letter of introduction, the research objective, the proposal or data analysis plan, the type of data or documents requested, and a confidentiality agreement. Requests will be reviewed by the principal investigator and, if necessary, by the ethics committee or the relevant academic authority. If approved, the de-identified data and related documents will be provided to the applicant after signing a data use agreement. The review and response process will usually be completed within 4 to 6 weeks after receipt of all required documents.