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NCT05229276
Efficacy of Sternum Guard in Post Cardiac Surgery Patient
NA trial testing Sternum Guard in Coronary Artery Disease in 414 participants. Completed in 30 October 2021.
8 October 2021
Quick facts
| Lead sponsor | Indonesia University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 414 |
| Start date | 17 May 2020 |
| Primary completion | 8 October 2021 |
| Estimated completion | 30 October 2021 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Sternum Guard
- Bone Wax
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Valvular Heart Disease — all drugs for Valvular Heart Disease →
- Congenital Heart Disease in Adolescence — all drugs for Congenital Heart Disease in Adolescence →
- Post Operative Wound Infection — all drugs for Post Operative Wound Infection →
Sponsor
Indonesia University
Who can join
Adults 18 to 75, any sex, with Coronary Artery Disease or Valvular Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, single-blind, randomized parallel superiority trial comparing two groups; Sternum GuardTM as the treatment arm and Bone Wax as the active control group. Both investigated modalities are materials used during sternotomy for covering the sewn sternal edge. The primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. The first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative.
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:
- PubMed search for NCT05229276
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05229276 (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 Indonesia University
- Last refreshed: 8 February 2022
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/NCT05229276.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing