POSITION: Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Surgical drain 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
In this arm a surgical drain will be inserted prior to surgical wound closure
|
| No Intervention: Control In this arm the subcutaneous tissue and the skin of the surgical wound will be sutured without insertion of any type of drain |
Outcome Measures
Primary Outcome Measures
- Prevalence of surgical site infection [Within 30 days]
Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site
- Risk of surgical debridement of surgical site infection [Within 30 days]
Rates of surgical intervention to treat surgical site infection will be recorded
Secondary Outcome Measures
- Risk of wound dehiscence [Within 30 days]
Rates of wound dehiscence (skin and/or fascia dehiscence) following surgical site infection or spontaneously (non-related to surgical site infection) will be recorded
- Length and depth of wound dehiscence [Within 30 days]
In case of wound dehiscence the length and depth will be measured in cm
- Risk of seroma formation [Within 30 days]
Rates of formation of seroma (defined as the collection of non-purulent fluid) in the surgical wound will be recorded.
- Risk and duration of fever related to surgical site infection [Within 30 days]
Rates of fever related to surgical site infection and following exclusion of other causes will be reported in degrees of Celsius
- Duration of antibiotic therapy directed against surgical site infection [Within 30 days]
The duration of post-operative use of antibiotics will be recorded in days
- Duration of hospitalization [Within 30 days]
Duration of hospitalization will be recorded in days
- Re-admission rates [Within 30 days]
Re-admission rates within 30 days will be reported
- Interval to adjuvant therapy [Within 30 days]
The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days
Other Outcome Measures
- Overall survival [3-year]
3-year survival rate
- Overall survival [5-year]
5-year survival rate
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- National and Kapodistrian University of Athens
- Aristotle University Of Thessaloniki
- Saint Savvas Anticancer Hospital
- Metaxa Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Mahdi H, Gojayev A, Buechel M, Knight J, SanMarco J, Lockhart D, Michener C, Moslemi-Kebria M. Surgical site infection in women undergoing surgery for gynecologic cancer. Int J Gynecol Cancer. 2014 May;24(4):779-86. doi: 10.1097/IGC.0000000000000126.
- Manzoor B, Heywood N, Sharma A. Review of Subcutaneous Wound Drainage in Reducing Surgical Site Infections after Laparotomy. Surg Res Pract. 2015;2015:715803. doi: 10.1155/2015/715803. Epub 2015 Dec 13. Review.
- Nugent EK, Hoff JT, Gao F, Massad LS, Case A, Zighelboim I, Mutch DG, Thaker PH. Wound complications after gynecologic cancer surgery. Gynecol Oncol. 2011 May 1;121(2):347-52. doi: 10.1016/j.ygyno.2011.01.026. Epub 2011 Feb 15.
- Pergialiotis V, Haidopoulos D, Tzortzis AS, Antonopoulos I, Thomakos N, Rodolakis A. The impact of waiting intervals on survival outcomes of patients with endometrial cancer: A systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:1-6. doi: 10.1016/j.ejogrb.2020.01.004. Epub 2020 Jan 7.
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