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

Surgical Incision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03861065
• Other study ID #: IRB00055298
• Secondary ID: NCI-2019-01292P3
• Status: Terminated
• Phase: N/A
• Start date: February 27, 2019
• Est. completion date: November 26, 2020

Study information

• Verified date: July 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: November 26, 2020
• Est. primary completion date: November 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Incision
• Surgical Wound

Intervention

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.
• Historical Wound Closure
Participants wounds are left partially open to heal.

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Comparisons of Tertiary Wound Closure Versus Historical Controls Postoperative Day 30	The percent of wound closure that occurs postoperative day #30 after tertiary wound closure as compared to historical controls receiving a secondary wound closure.	30 days after tertiary wound closure
Secondary	Proportions of Tertiary Technique Versus Historical Controls	The proportion of SSI using a tertiary closure technique compared to historical controls receiving a secondary would closure.	30 days after tertiary wound closure
Secondary	Length of Hospital Stay	The length of stay as defined by the time from surgery to discharge as compared to historical controls receiving a secondary would closure.	Up to 3 months after surgery
Secondary	Proportion of Patients Returning after Surgery	The proportion of patients that return within 30 days of surgery.	Up to 30 days after surgery
Secondary	Change of Quality of Life Questionnaire SF-36	The quality of life in patients receiving a tertiary wound closure. The scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Up to 3 months after tertiary wound closure