NCT05179122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

November 25, 2021

Last Update Submit

February 1, 2024

Conditions

Surgical Site InfectionGynecologic CancerWound Drain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Risk of wound dehiscence

    Within 30 days

  • Length and depth of wound dehiscence

    Within 30 days

  • Risk of seroma formation

    Within 30 days

  • Risk and duration of fever related to surgical site infection

    Within 30 days

  • Duration of antibiotic therapy directed against surgical site infection

    Within 30 days

  • +3 more secondary outcomes

Other Outcomes (2)

  • Overall survival

    3-year

  • Overall survival

    5-year

Study Arms (2)

Surgical drain

EXPERIMENTAL

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

Control

NO INTERVENTION

In this arm the subcutaneous tissue and the skin of the surgical wound will be sutured without insertion of any type of drain

Interventions

Surgical drainPROCEDURE

In this arm a surgical drain will be inserted prior to surgical wound closure

Surgical drain

Eligibility Criteria

Age30 Years - 85 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • This prospective randomized study will include obese (BMI\> 35) patients who will undergo primary surgery for ovarian or endometrial cancer

You may not qualify if:

  • Immunodeficient patients (systemic disease including HIV infection, systemic lupus erythematosus etc) Patients with hematologic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandra Hospital

Athens, Attica, 11528, Greece

Location

Related 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.

    PMID: 24681712BACKGROUND

  • 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.

    PMID: 21324517BACKGROUND

  • 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.

    PMID: 26783556BACKGROUND

  • 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.

    PMID: 31923876BACKGROUND

  • 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.

    PMID: 28209490RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician involved in the statistical analyses of results will be blinded to the arm of treatment
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

November 25, 2021

First Posted

January 5, 2022

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

January 15, 2024

Last Updated

February 2, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)