Post-Operative Antibiotic Efficacy in Clean Contaminated Head and Neck Surgery: A Randomized Controlled Trial

NCT06672471 | Enrolling By Invitation DMC

• 1 other identifier: IRB-24-32
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The "Post-Operative Antibiotic Efficacy in Clean Contaminated Head and Neck Surgery" (PEACH) trial is a study designed to assess the necessity of post-operative antibiotics for preventing surgical site infections (SSIs) in clean-contaminated head and neck surgeries. Recognizing the pivotal role antibiotics have played since their discovery in reducing postoperative infections, this trial aims to determine if a single perioperative antibiotic dose can effectively prevent SSIs, or if additional post-operative antibiotics are required. This study addresses a critical issue in the context of rising antibiotic resistance by potentially limiting unnecessary antibiotic use post-surgery while ensuring patient safety. Results could inform future guidelines, optimizing antibiotic use in surgical prophylaxis and contributing to global efforts against antibiotic resistance.

Conditions

Head and Neck Neoplasms; UADT Neoplasm; Cancer of the Head and Neck; Antibiotic Resistant Infection; Antibiotic Side Effect

Keywords

head; neck; cancer; surgery; ENT; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Incidence of Surgical Site Infection

  This will be assessed on Post Operative Physical Clinic visits and will be recorded by an assessor who will be blind to whether the patient received Post Operative antibiotic or not. SSI will be determined using a Clinical Examination and the findings will be recorded, pictures of the wound will be taken at every visit for up to four weeks to be uploaded in the patient's electronic records to be viewed later, A Standardized assessment (Looking for Spreading erythema, Localised pain, Pus or discharge from the wound, Persistent pyrexia, wound dehiscence) will be carried out by the clinician and the findings will be documented in patient electronic records in hospital information system (HIS).

  4 weeks after surgery

Secondary Outcomes (1)

• Rate of Post Operative Complications

  4 weeks after surgery

Study Arms (2)

Control Group Post operative Antibiotics

ACTIVE COMPARATOR

A Single dose of Peri-Operative Antibiotic at the time of induction of Anaesthesia before incision for surgery is made and additional Post Operative Antibiotics for one day. Antibiotic to be used: Cefazolin 2 Gram IV Once followed by Cefazolin 1 Gram TID

Other: Post Operative Antibiotics for one day

Intervention Group No Post Operative Antibiotics

EXPERIMENTAL

A Single dose of Peri-Operative Antibiotic at the time of induction of Anaesthesia before incision for surgery is made, the time of Antibiotics will be recorded in time-out form as a part of the surgical safety checklist. Antibiotic to be used: Cefazolin 2 Gram IV Once

Other: No Post Operative Antibiotics for intervention group

Interventions

No Post Operative Antibiotics for intervention group OTHER

No Post Operative Antibiotics in patients going clean contaminated head and neck surgery

Intervention Group No Post Operative Antibiotics

Post Operative Antibiotics for one day OTHER

Control group will receive perioperative as well as post operative antibiotics for one day

Control Group Post operative Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and older.
• Patients undergoing elective Clean-contaminated head and neck surgery.
• Patients who have provided informed consent.
• Patients with a life expectancy of more than 6 months.

You may not qualify if:

• Patients aged less than 18.
• Patients with a history of antibiotic allergies.
• Patients with ongoing infections or those requiring preoperative antibiotics.
• Patients with immunocompromised conditions (e.g., HIV, on immunosuppressive therapy).
• Patients undergoing emergency surgery.
• Patients undergoing palliative surgery.
• Patients undergoing Clean Head and Neck Surgery.

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre: lead

Study Sites (1)

Shaukat Khanum Memorial Cancer Hospital and Research Centre

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

• Watson AP, Tullo AB, Kerr-Muir MG, Ridgway AE, Lucas DR. Arborescent bacterial keratopathy (infectious crystalline keratopathy). Eye (Lond). 1988;2 ( Pt 5):517-22. doi: 10.1038/eye.1988.101.

  PMID: 3256489 BACKGROUND

• Righi M, Manfredi R, Farneti G, Pasquini E, Cenacchi V. Short-term versus long-term antimicrobial prophylaxis in oncologic head and neck surgery. Head Neck. 1996 Sep-Oct;18(5):399-404. doi: 10.1002/(SICI)1097-0347(199609/10)18:53.0.CO;2-0.

  PMID: 8864730 BACKGROUND

• Koshkareva YA, Johnson JT. What is the perioperative antibiotic prophylaxis in adult oncologic head and neck surgery? Laryngoscope. 2014 May;124(5):1055-6. doi: 10.1002/lary.24226. Epub 2013 Jun 10. No abstract available.

  PMID: 23754680 BACKGROUND

• Dhole S, Mahakalkar C, Kshirsagar S, Bhargava A. Antibiotic Prophylaxis in Surgery: Current Insights and Future Directions for Surgical Site Infection Prevention. Cureus. 2023 Oct 28;15(10):e47858. doi: 10.7759/cureus.47858. eCollection 2023 Oct.

  PMID: 38021553 BACKGROUND

• Shlykov IP. [Effect of somatotropin on the thyroid gland regeneration in hypophysectomized rats]. Probl Endokrinol (Mosk). 1969 Sep-Oct;15(5):69-74. No abstract available. Russian.

  PMID: 5354621 BACKGROUND

• Alanis AJ. Resistance to antibiotics: are we in the post-antibiotic era? Arch Med Res. 2005 Nov-Dec;36(6):697-705. doi: 10.1016/j.arcmed.2005.06.009.

  PMID: 16216651 BACKGROUND

• Adedeji WA. THE TREASURE CALLED ANTIBIOTICS. Ann Ib Postgrad Med. 2016 Dec;14(2):56-57. No abstract available.

  PMID: 28337088 BACKGROUND

• Stewart CL. The fire at Cocoanut Grove. J Burn Care Res. 2015 Jan-Feb;36(1):232-5. doi: 10.1097/BCR.0000000000000111.

  PMID: 25094013 BACKGROUND

• Fleming A. On the antibacterial action of cultures of a penicillium, with special reference to their use in the isolation of B. influenzae. 1929. Bull World Health Organ. 2001;79(8):780-90. No abstract available.

  PMID: 11545337 BACKGROUND

• Aminov RI. A brief history of the antibiotic era: lessons learned and challenges for the future. Front Microbiol. 2010 Dec 8;1:134. doi: 10.3389/fmicb.2010.00134. eCollection 2010.

  PMID: 21687759 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

• Dr. Syed Raza Hussain Consultant Oro-Maxillo-Facial Surgeon, MBBS, BDS, FDSRCS (ENG,IRL)

  Shaukat Khanum Memorial Cancer Hospital and Research Centre

  STUDY CHAIR

• Dr. Muhammad Faisal Consultant Head & Neck Surgery, BDS,FCPS,FHNS

  Shaukat Khanum Memorial Cancer Hospital and Research Centre

  STUDY CHAIR

• Dr. Shayan Khalid Ghaloo Senior Instructor Head & Neck Surg., MBBS,FCPS

  Shaukat Khanum Memorial Cancer Hospital and Research Centre

  STUDY DIRECTOR

• Dr. Muhammad Awais Kanwal, MBBS,B.Sc

  Shaukat Khanum Memorial Cancer Hospital and Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study uses a triple blinded trial design to reduce bias, ensuring that neither the primary clinical teams, the patients, nor the post-operative assessors know the assigned treatment groups. The surgical and anesthetic teams performing the operation are blinded to group allocation, following standard care protocols without knowing if a patient receives postoperative antibiotics. Similarly, assessors who evaluate patients for surgical site infections (SSIs) during follow-up are blinded, preventing any influence on SSI assessment from knowledge of the patient's treatment group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Muhammad Awais Kanwal Department of Surgical Oncology

Model Details: To determine whether postoperative antibiotic prophylaxis is necessary in patients undergoing Clean-contaminated head and neck surgery, or if a single perioperative antibiotic dose suffices. Primary Outcome Measure: Incidence of Surgical Site infection (SSI) This will be assessed on Post Operative Physical Clinic visits and will be recorded by an assessor who will be blind to whether the patient received Post Operative antibiotic or not. Secondary Outcome Measure: Post-Operative Complications The Secondary outcome measure, post-operative complications will be recorded as per the Clavien Dindo Classification (CDC)

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: November 15, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We Plan to Share once study has been concluded.
• Access Criteria: Requests will be seen on case to case basis.

Locations

PA (1)