Gynecological Cancer, Supplemental Oxygen, Surgical Site Infections
Conditions
Keywords
Supplemental oxygen, Surgical site infections, Gynecological cancer
Brief summary
The incidence of surgical-site infection (SSI) and complications related to wound healing reaches 10-20% of gynecological cancer patients. Each complication may dramatically prolong the hospitalization period and increase the economic burden of hospital care. Appropriate wound care and tissue oxygenation are of special importance for wound healing. Assuming adequate perfusion, the easiest, safest, and most effective way to improve tissue oxygenation is to increase the fraction of inspired oxygen. However, there is considerable controversy as to whether supplemental oxygen actually reduces SSI and healing-related complications as to date, there is absence of relevant data.
Detailed description
This study aims to investigate the prophylactic value of postoperative oxygen administration against the development of wound infections in obese gynecological oncology patients undergoing laparotomy for the treatment of endometrial or ovarian cancer. At the same time, the factors that lead to an increase in this risk will be outlined.
Interventions
BEHAVIORALSupplemental oxygen therapy
In this grou participants will receive supplemental oxygen in the form of a Venturi mask upon low oxygen saturation in oximetry (SaO2\<95%) and a nasal oxygen mask in all other cases during the first 2 postoperative days
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will be assigned with computer-generated randomization in two groups: i) the group receiving supplemental oxygen in the form of a Venturi mask upon low oxygen saturation in oximetry (SaO2\<95%) and a nasal oxygen mask in all other cases during the first 2 postoperative days (phase of hemostasis and inflammation of the surgical wound as well as ii) the control group in which supplemental oxygen will not be administered beyond the basic indications (low saturation, respiratory dysfunction).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Obese (BMI\>30kg/m2) gynecological cancer patients * Optimized preoperative CBC values (hemoglobin \>11g/dl, WBC 4.000-11.000 X 109/L, platelets 150,000 to 400,000 X 109/L) * In the case of neoadjuvant therapy an interval longer than three weeks between the last cycle and the operation
Exclusion criteria
* Active immunosuppresion * Preexisting infection of the abdominal wall * Preexisting sepsis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infections | Within 30 days from the operation | Surgical site infections will be evaluated using the Southampton wound scoring system |
| Systemic inflammatory response syndrome | Within 30 days from the operation | The proportion of patients developing SSI-related systemic inflammatory response will be documented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroma formation | Within 30 days from the operation | The development of wound seroma will be recorded |
| Wound hematoma | Within 30 days from the operation | The formation of wound hematoma will be evaluated |
| Uncomplicated wound healing | Within 30 days from the operation | The proportion of patients with no apparent wound healing problems will be documented |
| Additional wound assisting devices | Within 30 days from the operation | The need for vacuum assisted wound healing will be documented |
| Need for surgical debridement | Within 30 days from the operation | Need for surgical debridement (bedside or on the operation theatre) |
| Multidrug resistant pathogens | Within 30 days from the operation | The proportion of patients with multidrug-resistant pathogens involving SSI will be documented |
| Duration of hospitalization | Within 30 days from the operation | The total duration of hospitalization will be documented |
| Hospital readmissions related to SSI | Within 30 days from the operation | Readmissions related to SSIs will be documented |
| Antibiotic coverage | Within 30 days from the operation | The need for supplemental antibiotic coverage will be documented |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infectious morbidity | Within 30 days from the operation | Other infectious morbidity, including urinary tract, pulmonary and gastrointestinal infections will be recorded |
| Non-SSI related hospital readmissions | Within 30 days from the operation | Hospital readmission rates that are not attributed to SSIs will be documented |
| Postoperative morbidity | Within 30 days from the operation | Postoperative morbidity non-related to SSI will be documented using the Clavien-Dindo scaling score |
Countries
Greece
Contacts
Primary ContactVasilios Pergialiotis, Assistant Professor
Outcome results
None listed