The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery
The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Wound infections are common and serious complications of anesthesia and surgery. The morbidity associated with surgical infections is considerable and includes substantial prolongation of hospitalization.
The wound infection risk in patients undergoing cardiac surgery ranges from 0.8 to 17.7% including both superficial and deep sternal infections.
Major factors influencing the incidence of surgical wound infection other than site and complexity of surgery, underlying illness, timely administration of prophylactic antibiotics, intraoperative patient temperature, hypovolemia and tissue oxygen tension. The primary determinant of tissue oxygen availability is local perfusion. Thermoregulatory status is one of the major factors influencing tissue perfusion. Local warming induces pre- capillary vasodilation and improves tissue oxygenation. Local warming of surgical wounds may provide a simple and inexpensive way to reduce perioperative wound complications. Specifically, we will test the hypothesis that Warm- Up therapy increases postoperative tissue oxygen tension in patients undergoing cardiopulmonary bypass.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Vienna, Austria, 1090
- Medical University Vienna
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate
Exclusion Criteria:
- Emergency surgery
- Pre - or postoperative on intraaortic balloon pump
- Preoperative mechanical ventilation
- Postoperative respiratory failure
- Postoperative extracorporal membrane oxygenation
- Left ventricular function < 40%
- Fever (core temperature > 38 °C) or current infection
- No anticipated or no definitive primary closure of surgical wound.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: conventional bandage
conventional bandage on sternal wound after skin closure after cardiac surgery.
conventional gauze covered with elastic adhesive (Medipore™ Dress-it) The designated bandage will be positioned in the operating room by the surgeons after the skin will be closed.
The conventional elastic bandage consists of several layers of gauze covered with a special adhesive bandage
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Comparatore attivo: warming bandage
The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound.
A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound.
The surface temperature of heating card is fixed at 38°C, and heat is usually provided for two hours at a time.
That is, the experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Tissue Oxygenation Levels
Lasso di tempo: 2 years
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2 years
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Tissue Oxygen Tension in the Sternal Wound
Lasso di tempo: 8 hours
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Tissue oxygen tension in the wound Tissue oxygen tension will be measured with a polarographic electrode system (Licox CMP, GMS Germany), the oxygen electrode will be calibrated with room air (154 mmHg) and then positioned within the silastic tonometer that will be inserted 2 3 cm lateral to the surgical incision.
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8 hours
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Barbara Kabon, MD, Medical University Vienna,Spitalgasse 23, 1090 Vienna, Austria
- Investigatore principale: Helmut Hager, MD, Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austra
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
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Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 1.0
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