Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Prophylactic subcutaneous closed-suction drainage: Placement 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: Standardized subcutaneous tissue approximation and skin closure without placement of a prophylactic subcutaneous drain.

Study summary

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

Primary outcome measure(s)

• Composite wound complication within 30 postoperative days — Up to 30 days after surgery
  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.

Trial sites (1)

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