Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMahmut Yassa
About this trial
The goal of this clinical trial is to learn whether placing a small drain under the skin can help prevent wound problems after gynecologic oncology surgery in adult women with a thick layer of tissue under the skin.
The main question it aims to answer is:
Does a small drain placed under the skin lower the number of wound complications within 30 days after surgery?
Researchers will compare two groups:
Participants in one group will have a small closed-suction drain placed under the skin before the skin is closed.
Participants in the other group will not have a drain placed under the skin.
All participants will have midline abdominal surgery. During surgery, the surgeon will measure the thickness of the tissue under the skin. Participants with a thickness of 2.5 cm or more will be randomly assigned to one of the two groups.
In both groups, the tissue under the skin will be closed in a standard way using separate 2/0 Vicryl stitches. Participants in the drain group will have the drain removed when the amount of fluid collected in 24 hours is less than 30 mL, unless the surgeon decides that earlier or later removal is needed.
Participants will be followed for 30 days after surgery to check for wound problems such as infection, wound separation, fluid collection, blood collection, or the need for extra wound care or another procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged 18 years or older
Undergoing midline laparotomy for gynecologic oncology surgery
Intraoperative subcutaneous tissue thickness of 2.5 cm or greater, measured at the thickest part of the incision
Able and willing to provide written informed consent before surgery
Disqualifiers
Emergency surgery
Active infection before surgery
Severe immunosuppression
Refusal to provide written informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Prophylactic subcutaneous closed-suction drainage
Procedure/SurgeryPlacement of a closed-suction drain in the subcutaneous tissue before skin closure in patients with intraoperative subcutaneous tissue thickness of 2.5 cm or greater.
Standard closure without subcutaneous drainage
Procedure/SurgeryStandardized subcutaneous tissue approximation and skin closure without placement of a prophylactic subcutaneous drain.
Treatment groups
334 Participants
are divided into 2 treatment groupsGroup A: Subcutaneous DrainExperimental treatment 1 intervention
Group B: No Subcutaneous DrainActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite wound complication within 30 postoperative days
The primary outcome is the incidence of composite wound complication within 30 postoperative days. Composite wound complication is defined as the occurrence of at least one of the following: surgical site infection, wound dehiscence, clinically significant subcutaneous seroma, clinically significant subcutaneous hematoma, or wound-related intervention. Clinically significant subcutaneous seroma or hematoma is defined as a seroma or hematoma requiring any additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention. Wound-related intervention is defined as any wound-directed procedure (aspiration, drainage, re-suturing, surgical revision, or operative wound debridement) performed because of a postoperative wound complication, in either an inpatient or outpatient setting.
Time frame
Up to 30 days after surgerySecondary outcomes
1
Surgical site infection within 30 postoperative days
Incidence of surgical site infection within 30 postoperative days, including superficial or deep incisional surgical site infection as clinically diagnosed and recorded during postoperative follow-up.
Time frame
Up to 30 days after surgery2
Wound dehiscence within 30 postoperative days
Incidence of wound dehiscence within 30 postoperative days, including superficial or deep wound separation documented during postoperative follow-up.
Time frame
Up to 30 days after surgery3
Clinically significant subcutaneous seroma within 30 postoperative days
Incidence of clinically significant subcutaneous seroma within 30 postoperative days. Clinically significant seroma is defined as a seroma requiring additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention.
Time frame
Up to 30 days after surgery4
Clinically significant subcutaneous hematoma within 30 postoperative days
Incidence of clinically significant subcutaneous hematoma within 30 postoperative days. Clinically significant hematoma is defined as a hematoma requiring additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention.
Time frame
Up to 30 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Mahmut Yassa
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Sponsor institution
Source ClinicalTrials.gov