Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION

Surgical Site Infection Clinical Trial

— POSITION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05179122
• Other study ID #: 699/8-11-21
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 15, 2024

Study information

• Verified date: February 2024
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 15, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Infections
• Surgical Site Infection
• Surgical Wound Infection
• Wounds and Injuries

Intervention

Procedure:
• Surgical drain
In this arm a surgical drain will be inserted prior to surgical wound closure

Locations

Country	Name	City	State
Greece	Alexandra Hospital	Athens	Attika

Sponsors (4)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	Aristotle University Of Thessaloniki, Metaxa Hospital, Saint Savvas Anticancer Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Steiner HL, Strand EA. Surgical-site infection in gynecologic surgery: pathophysiology and prevention. Am J Obstet Gynecol. 2017 Aug;217(2):121-128. doi: 10.1016/j.ajog.2017.02.014. Epub 2017 Feb 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	3-year survival rate	3-year
Other	Overall survival	5-year survival rate	5-year
Primary	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
Primary	Risk of surgical debridement of surgical site infection	Rates of surgical intervention to treat surgical site infection will be recorded	Within 30 days
Secondary	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
Secondary	Length and depth of wound dehiscence	In case of wound dehiscence the length and depth will be measured in cm	Within 30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Duration of hospitalization	Duration of hospitalization will be recorded in days	Within 30 days
Secondary	Re-admission rates	Re-admission rates within 30 days will be reported	Within 30 days
Secondary	Interval to adjuvant therapy	The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days	Within 30 days