Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION

Study Overview
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Brief Summary
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The aim of the present randomized trial is to assess the efficacy of wound drains in terms of reducing the rates of surgical site infection in obese patients with gynecological cancer.

Detailed Description
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Many prophylactic methods have been suggested for the treatment of surgical wound infections, including the prolonged administration of antibiotics as well as the use of subcutaneous tissue drainage, the use of which has been shown to be particularly effective in overweight patients. While its importance seems to be moderate in obese patients as well as those that suffer from malignant disease, to date, it remains unknown if wound drains may help reduce the rates of surgical site infection in obese patients that suffer from cancer. In the field of gynecological oncology data are limited to anachronistic studies whose methodological value is limited; hence, guidelines are primarily based in data of high risk of bias as to date, the value of subcutaneous tissue drainage in obese women undergoing surgery for gynecological cancer has not been documented in a large randomized study. Considering the significant impact of surgical site infection on the interval to adjuvant therapy (as patients with infectious diseases cannot receive chemotherapy or radiotherapy), it becomes evident that every effort has to be made in order to help reduce the rates of SSI to help maintain acceptable intervals that will ensure appropriate care of patients.

Official Title
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A Randomized Trial of Abdominal Wound Drainage in Obese Gynecologic Oncology Patients

Conditions
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Surgical Site Infection, Gynecologic Cancer, Wound Drain

Intervention / Treatment
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* Procedure: Surgical drain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This prospective randomized study will include obese (BMI> 35) patients who will undergo primary surgery for ovarian or endometrial cancer Exclusion Criteria: Immunodeficient patients (systemic disease including HIV infection, systemic lupus erythematosus etc) Patients with hematologic diseases

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical drain<br>In this arm participants a surgical drain (Redon type) will be inserted above the abdominal fascia prior to suture of the subcutaneous tissue and of the skin | Procedure: Surgical drain<br>* In this arm a surgical drain will be inserted prior to surgical wound closure<br>|
| No Intervention: Control<br>In this arm the subcutaneous tissue and the skin of the surgical wound will be sutured without insertion of any type of drain | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of surgical site infection | Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site | Within 30 days | 
| Risk of surgical debridement of surgical site infection | Rates of surgical intervention to treat surgical site infection will be recorded | Within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of wound dehiscence | Rates of wound dehiscence (skin and/or fascia dehiscence) following surgical site infection or spontaneously (non-related to surgical site infection) will be recorded | Within 30 days | 
| Length and depth of wound dehiscence | In case of wound dehiscence the length and depth will be measured in cm | Within 30 days | 
| Risk of seroma formation | Rates of formation of seroma (defined as the collection of non-purulent fluid) in the surgical wound will be recorded. | Within 30 days | 
| Risk and duration of fever related to surgical site infection | Rates of fever related to surgical site infection and following exclusion of other causes will be reported in degrees of Celsius | Within 30 days | 
| Duration of antibiotic therapy directed against surgical site infection | The duration of post-operative use of antibiotics will be recorded in days | Within 30 days | 
| Duration of hospitalization | Duration of hospitalization will be recorded in days | Within 30 days | 
| Re-admission rates | Re-admission rates within 30 days will be reported | Within 30 days | 
| Interval to adjuvant therapy | The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days | Within 30 days |