NCT03861065

Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if closing a surgical wound differently is better than the procedure that is currently used. The wound will be closed with what is considered "tertiary intent." This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. The investigators also want to see how this new wound closure process affects your quality of life.

Detailed description

Primary Objective To compare the percentage of patients whose wound remained closed on postoperative day #30 after tertiary closure compared to historical controls who underwent secondary would closure. We are primarily looking at time to wound closure. We will be able to abstract this information from the postoperative clinic visit notes from patients in the "historical control" cohort. We will identify 20 patients with characteristics described in the inclusion criteria of this study who underwent laparotomy with secondary would closure during the calendar year 2018. Secondary Objectives To compare the proportion of acute and chronic wound infection in wounds closed with a tertiary closure technique to historical controls receiving a secondary wound closure. To compare the length of stay of patients receiving a tertiary wound closure to historical controls receiving a secondary wound closure. To describe the number of patients receiving a tertiary wound closure that return within 30 days of surgery as compared to historical controls receiving a secondary wound closure. To describe the quality of life in patients receiving a tertiary wound closure.

Conditions

• Surgical Incision

Interventions

Type	Name	Description
PROCEDURE	Tertiary Wound Closure	The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
PROCEDURE	Historical Wound Closure	Participants wounds are left partially open to heal.

Timeline

• Start date: 2019-02-27
• Primary completion: 2020-11-26
• Completion: 2020-11-26
• First posted: 2019-03-04
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

1 site across 1 country: United States