Who is sponsoring NCT04218110?

NCT04218110 is sponsored by Professional Disposables International, Inc..

What condition does NCT04218110 study?

NCT04218110 studies Surgical Site Infection.

Is NCT04218110 still recruiting?

NCT04218110 is currently completed. Last updated 22 October 2021.

Are results published for NCT04218110?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-10-22 · How we verify

NCT04218110

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances

Completed Phase 3 Results posted Last updated 22 October 2021

What this trial tests

Phase 3 trial testing Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic in Surgical Site Infection in 329 participants. Completed in 31 March 2020.

Timeline

11 February 2020

Primary endpoint
10 March 2020

31 March 2020

Quick facts

Lead sponsor	Professional Disposables International, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	329
Start date	11 February 2020
Primary completion	10 March 2020
Estimated completion	31 March 2020
Sites	1 location across Romania

Drugs / interventions tested

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic — full drug profile →
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic — full drug profile →
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic — full drug profile →
Prevantics 3.15 % / 70 % Swabstick — full drug profile →

Conditions studied

Surgical Site Infection — all drugs for Surgical Site Infection →

Sponsor

Professional Disposables International, Inc. — full company profile →

Who can join

18 and older, any sex, with Surgical Site Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Bacterial Microflora in the Inguinal Area Primary · 10 minutes

Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention

Group	Value	95% CI
Project X 26ml	-3.86	± 1.58
Project X 10.5ml	-4.34	± 1.48
Project X 5.1ml	-3.65	± 1.36
Prevantics Maxi Swabstick	-3.80	± 1.42

Change in Bacterial Microflora in the Inguinal Area Secondary · 30 seconds

Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention

Group	Value	95% CI
Project X 26ml	-3.86	± 1.55
Project X 10.5ml	-3.76	± 1.36
Project X 5.1ml	-3.70	± 1.58
Prevantics Maxi Swabstick	-3.76	± 1.48

Adverse events — posted to ClinicalTrials.gov

Time frame: 1.5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Project X 26ml

Serious: 0/82 (0%)

Deaths: 0/82

Project X 10.5ml

Serious: 0/81 (0%)

Deaths: 0/81

Project X 5.1ml

Serious: 0/83 (0%)

Deaths: 0/83

Prevantics Maxi Swabstick

Serious: 0/82 (0%)

Deaths: 0/82

Other adverse events (1 terms — click to expand)

Reaction	System	Project X 26ml	Project X 10.5ml	Project X 5.1ml	Prevantics Maxi Swabstick
Adverse Event	Pregnancy, puerperium and perinatal conditions	—	—	—	—

Data from ClinicalTrials.gov NCT04218110 adverse events section.

Sponsor's own description

Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml Project X, 5.1ml Project X and Prevantics Maxi swabstick following ASTM E1173 - Standard test method for evaluation of preoperative, precatheterization or preinjection skin preparations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Surgical Site Infection

Currently open trials in the same condition.

NCT07501897 — Investigating the Impact of Cold Atmospheric Plasma Treatment on Wound Healing at Cannulation Sites in Patients Followin · NA · recruiting
NCT07311395 — Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section · NA · recruiting
NCT06649890 — A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™ · NA · recruiting
NCT07005635 — The Effects of Different Time Reminder On Surgical Hand Scrubing · NA · active not recruiting
NCT07049614 — Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients · active not recruiting

Other Professional Disposables International, Inc. trials

Trials by the same sponsor.

NCT03861780 — Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation · Phase 3 · completed
NCT03817580 — Comparative Study of Antimicrobial Effectiveness · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04218110 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Professional Disposables International, Inc.
Last refreshed: 22 October 2021

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/NCT04218110.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing