Clinical trial NCT05179122: Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION
Official title: A Randomized Trial of Abdominal Wound Drainage in Obese Gynecologic Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Gynecologic Cancer
Wound Drain
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
name: Saint Savvas Anticancer Hospital
name: Metaxa Hospital
First posted: 2022-01-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of surgical site infection
timeFrame: Within 30 days
measure: Risk of surgical debridement of surgical site infection
timeFrame: Within 30 days
Secondary outcomes:
measure: Risk of wound dehiscence
timeFrame: Within 30 days
measure: Length and depth of wound dehiscence
timeFrame: Within 30 days
measure: Risk of seroma formation
timeFrame: Within 30 days
measure: Risk and duration of fever related to surgical site infection
timeFrame: Within 30 days
measure: Duration of antibiotic therapy directed against surgical site infection
timeFrame: Within 30 days
measure: Duration of hospitalization
timeFrame: Within 30 days
measure: Re-admission rates
timeFrame: Within 30 days
measure: Interval to adjuvant therapy
timeFrame: Within 30 days
Other outcomes:
measure: Overall survival
timeFrame: 3-year
measure: Overall survival
timeFrame: 5-year
Locations:
city: Athens
country: Greece
facility: Alexandra Hospital
state: Attika
Study officials:
References:
citation: 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.
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.
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.
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.
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.