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

Wake Forest University (WFU)

Status: Terminated

Conditions: Surgical Incision

Treatments: Procedure: Historical Wound Closure; Procedure: Tertiary Wound Closure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03861065

P30CA012197 (U.S. NIH Grant/Contract)

NCI-2019-01292 (Other Identifier)

CCCWFU04418 (Other Identifier)

IRB00055298

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with high risk class II, class III, class IV abdominal wounds
• Undergoing laparotomy for gynecologic related disorders
• Patients undergoing laparotomy for both benign and malignant diagnoses will be included in this study

Exclusion criteria

• Pregnancy
• Allergy to triclosan
• Patients undergoing HIPEC

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 2 patient groups

Tertiary Wound Closure

Experimental group

Description:

In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.

Treatment:

Procedure: Tertiary Wound Closure

Historical Wound Closure

Active Comparator group

Description:

The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").

Treatment:

Procedure: Historical Wound Closure