Clinical trial NCT03861065: Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
Official title: Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Incision
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-04
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Comparisons of Tertiary Wound Closure Versus Historical Controls Postoperative Day 30
timeFrame: 30 days after tertiary wound closure
Secondary outcomes:
measure: Proportions of Tertiary Technique Versus Historical Controls
timeFrame: 30 days after tertiary wound closure
measure: Length of Hospital Stay
timeFrame: Up to 3 months after surgery
measure: Proportion of Patients Returning after Surgery
timeFrame: Up to 30 days after surgery
measure: Change of Quality of Life Questionnaire SF-36
timeFrame: Up to 3 months after tertiary wound closure
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael G Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References: