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Efficacy of Sternum Guard in Post Cardiac Surgery Patient

NCT05229276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2022-02-08

No results posted yet for this study

Summary

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.

Conditions

  • Coronary Artery Disease
  • Valvular Heart Disease
  • Congenital Heart Disease in Adolescence
  • Post Operative Wound Infection
  • Surgical Site Infection
  • Postoperative Hemorrhage

Interventions

OTHER

Sternum Guard

The intervention being assessed is a surgical drape used as a cover of sternal bones and the neighboring structures exposed during median sternotomy named Sternum Guard. Sternum guard® is a single use, sterile surgical drape with modified cellulose designed specifically to reduce the risk of surgical site infection (SSI). It is made of 4 parts, the main part is in contact with the retractors and the sternum edge. It is made of carboxymethylated cellulose (CMC) spunlace which makes direct contact with the sternum edges. It contributes to blood absorption, to decreasing of pH environment, and to haemostatic action through a physical effect (compression); another part was made from hydrophilic spunbond (swabs) allowing blood absorption, comfort and protection

OTHER

Bone Wax

patients in this group were given Bone Wax as the hemostatic material during sternotomy. Midline sternotomy with an oscillating saw was conducted after standard aseptic surgical techniques. Bone wax was applied to both spongiosa surfaces of resected sternal bones until bleeding had ceased.

Sponsors & Collaborators

  • Vygon GmbH & Co. KG

    collaborator INDUSTRY

  • Indonesia University

    lead OTHER

Principal Investigators

  • Komite Etik of National Cardiovascular Center Harapan Kita · Ethical Committee of National Cardiovascular Center Harapan Kita

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-17
Primary Completion
2021-10-08
Completion
2021-10-30

Countries

  • Indonesia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229276 on ClinicalTrials.gov