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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemental oxygen | Active Comparator | This group 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 case of normal oxygen saturation) for the first 2 postoperative days |
|
| Control group | No Intervention | This group will not receive supplemental oxygen during the first two days of hospitalization |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental oxygen therapy | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infections | Surgical site infections will be evaluated using the Southampton wound scoring system | Within 30 days from the operation |
| Systemic inflammatory response syndrome | The proportion of patients developing SSI-related systemic inflammatory response will be documented | Within 30 days from the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Need for surgical debridement | Need for surgical debridement (bedside or on the operation theatre) | Within 30 days from the operation |
| Seroma formation | The development of wound seroma will be recorded |
| Measure | Description | Time Frame |
|---|---|---|
| Infectious morbidity | Other infectious morbidity, including urinary tract, pulmonary and gastrointestinal infections will be recorded | Within 30 days from the operation |
| Postoperative morbidity | Postoperative morbidity non-related to SSI will be documented using the Clavien-Dindo scaling score |
Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasilios Pergialiotis, Assistant Professor | Contact | +302132162291 | pergialiotis@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Thomakos, Associate Professor | National and Kapodistrian University of Athens | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First department of Obstetrics and Gynecology | Recruiting | Athens | 11528 | Greece |
IPD will not be shared for this study
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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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).
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| Within 30 days from the operation |
| Wound hematoma | The formation of wound hematoma will be evaluated | Within 30 days from the operation |
| Uncomplicated wound healing | The proportion of patients with no apparent wound healing problems will be documented | Within 30 days from the operation |
| Additional wound assisting devices | The need for vacuum assisted wound healing will be documented | Within 30 days from the operation |
| Antibiotic coverage | The need for supplemental antibiotic coverage will be documented | Within 30 days from the operation |
| Multidrug resistant pathogens | The proportion of patients with multidrug-resistant pathogens involving SSI will be documented | Within 30 days from the operation |
| Duration of hospitalization | The total duration of hospitalization will be documented | Within 30 days from the operation |
| Hospital readmissions related to SSI | Readmissions related to SSIs will be documented | Within 30 days from the operation |
| Within 30 days from the operation |
| Non-SSI related hospital readmissions | Hospital readmission rates that are not attributed to SSIs will be documented | Within 30 days from the operation |
| D013568 |
| Pathological Conditions, Signs and Symptoms |