Efficacy of Sternum Guard in Post Cardiac Surgery Patient

NACompletedINTERVENTIONAL
Enrollment

414

Participants

Timeline

Start Date

May 17, 2020

Primary Completion Date

October 8, 2021

Study Completion Date

October 30, 2021

Conditions
Coronary Artery DiseaseValvular Heart DiseaseCongenital Heart Disease in AdolescencePost Operative Wound InfectionSurgical Site InfectionPostoperative 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.

Trial Locations (1)

11410

National Cardiovascular Center Harapan Kita, Jakarta

All Listed Sponsors
collaborator

Vygon GmbH & Co. KG

INDUSTRY

lead

Indonesia University

OTHER

NCT05229276 - Efficacy of Sternum Guard in Post Cardiac Surgery Patient | Biotech Hunter | Biotech Hunter