Clinical trial · Interventional
Post-Operative Antibiotic Efficacy in Clean Contaminated Head and Neck Surgery: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antibiotic Resistant Infection | — | UNRESOLVED | — |
| Antibiotic Side Effect | — | UNRESOLVED | — |
| Cancer of the Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| UADT Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Post Operative Antibiotics for intervention group | Other | — | UNRESOLVED |
| Post Operative Antibiotics for one day | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group Post operative Antibiotics
- description
- 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
- interventionNames
- Other: Post Operative Antibiotics for one day
- type
- EXPERIMENTAL
- label
- Intervention Group No Post Operative Antibiotics
- description
- 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
- interventionNames
- Other: No Post Operative Antibiotics for intervention group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged 18 years and older. 2. Patients undergoing elective Clean-contaminated head and neck surgery. 3. Patients who have provided informed consent. 4. Patients with a life expectancy of more than 6 months. Exclusion Criteria: 1. Patients aged less than 18. 2. Patients with a history of antibiotic allergies. 3. Patients with ongoing infections or those requiring preoperative antibiotics. 4. Patients with immunocompromised conditions (e.g., HIV, on immunosuppressive therapy). 5. Patients undergoing emergency surgery. 6. Patients undergoing palliative surgery. 7. Patients undergoing Clean Head and Neck Surgery.
References
Publications (10)
- BACKGROUNDWatson 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
- BACKGROUNDRighi 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
- BACKGROUNDKoshkareva 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
- BACKGROUNDDhole 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
- BACKGROUNDShlykov 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
- BACKGROUNDAlanis 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
- BACKGROUNDAdedeji WA. THE TREASURE CALLED ANTIBIOTICS. Ann Ib Postgrad Med. 2016 Dec;14(2):56-57. No abstract available. PMID 28337088
- BACKGROUNDStewart CL. The fire at Cocoanut Grove. J Burn Care Res. 2015 Jan-Feb;36(1):232-5. doi: 10.1097/BCR.0000000000000111.