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NCT03574090: PROTOP
Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery
Phase 4 trial testing Amoxicillin Clavulanate in Surgical Wound Infection in 268 participants. Completed in 11 June 2023.
30 May 2023
Quick facts
| Lead sponsor | Universitat Internacional de Catalunya |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 268 |
| Start date | 20 October 2020 |
| Primary completion | 30 May 2023 |
| Estimated completion | 11 June 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Amoxicillin Clavulanate
- Physiological Saline — full drug profile →
Conditions studied
- Surgical Wound Infection — all drugs for Surgical Wound Infection →
- Postoperative Wound Infection — all drugs for Postoperative Wound Infection →
- Postoperative Wound Infection Superficial Incisional — all drugs for Postoperative Wound Infection Superficial Incisional →
- Preventive Therapy — all drugs for Preventive Therapy →
Sponsor
Universitat Internacional de Catalunya — full company profile →
Who can join
18 and older, any sex, with Surgical Wound Infection or Postoperative Wound Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective is to study the efficacy of topical antibiotic therapy with Amoxicillin / Clavulanic acid in the prevention of surgical wound infection in patients undergoing to colorectal surgery
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Antimicrobial approach of abdominal post-surgical infections.
Fiore M, Corrente A, Di Franco S, Alfieri A, et al · · 2023 · cited 6× · PMID 38222012 · DOI 10.4240/wjgs.v15.i12.2674
Verify or expand the search:
- PubMed search for NCT03574090
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Amoxicillin Clavulanate
Trials testing the same drug.
- NCT05393505 — Fast-track Blood Test for Suspected Fever by Deficiency of a Kind of White Blood Cells As Main Defense Against Infection · Phase 4 · unknown
- NCT04698057 — Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Pro · Phase 3 · withdrawn
- NCT04629378 — Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB · Phase 2 · completed
- NCT04268407 — 2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy · NA · completed
- NCT04041791 — A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia · Phase 3 · completed
Other recruiting trials for Surgical Wound Infection
Currently open trials in the same condition.
- NCT07379684 — A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections · Phase 1 · recruiting
- NCT07382973 — Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control · NA · recruiting
- NCT06702878 — Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections · Phase 3 · active not recruiting
- NCT06477770 — Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time · NA · active not recruiting
- NCT06420934 — Surgical Handwashing: Drying With One or Two Surgical Towels · NA · recruiting
Other Universitat Internacional de Catalunya trials
Trials by the same sponsor.
- NCT07478159 — Maternal Musculoskeletal Factors of the Hip, Lumbopelvic, Abdominal and Pelvic Floor Regions and Their Association With · not yet recruiting
- NCT07415486 — Immediate Implants in Front Teeth With Bone Loss: Regeneration and Temporary Crown in a Randomized Clinical Study · NA · not yet recruiting
- NCT07405541 — Knowledge of Periodontitis and Its Relation to Periodontal Health · not yet recruiting
- NCT07417293 — Clinical and Patient Outcomes of 4 mm Ultra-Short vs. 8 mm Implants With Bone Augmentation in the Back Upper Jaw · NA · not yet recruiting
- NCT07329244 — Graphene-Reinforced CAD/CAM Restorations for MIH-Affected Molars in Adolescents: A Prospective Clinical Study · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03574090 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitat Internacional de Catalunya
- Last refreshed: 13 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03574090.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing