Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
Primary Purpose
Surgical Incision
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tertiary Wound Closure
Historical Wound Closure
Sponsored by
About this trial
This is an interventional supportive care trial for Surgical Incision
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
Sites / Locations
- Comprehensive Cancer Center of Wake Forest University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tertiary Wound Closure
Historical Wound Closure
Arm 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.
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").
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Proportion of Patients Returning after Surgery
The proportion of patients that return within 30 days of surgery.
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.
Full Information
NCT ID
NCT03861065
First Posted
February 25, 2019
Last Updated
August 18, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03861065
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
November 26, 2020 (Actual)
Study Completion Date
November 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tertiary Wound Closure
Arm Type
Experimental
Arm 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.
Arm Title
Historical Wound Closure
Arm Type
Active Comparator
Arm 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").
Intervention Type
Procedure
Intervention Name(s)
Tertiary Wound Closure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Historical Wound Closure
Intervention Description
Participants wounds are left partially open to heal.
Primary Outcome Measure Information:
Title
Percentage Comparisons of Tertiary Wound Closure Versus Historical Controls Postoperative Day 30
Description
The percent of wound closure that occurs postoperative day #30 after tertiary wound closure as compared to historical controls receiving a secondary wound closure.
Time Frame
30 days after tertiary wound closure
Secondary Outcome Measure Information:
Title
Proportions of Tertiary Technique Versus Historical Controls
Description
The proportion of SSI using a tertiary closure technique compared to historical controls receiving a secondary would closure.
Time Frame
30 days after tertiary wound closure
Title
Length of Hospital Stay
Description
The length of stay as defined by the time from surgery to discharge as compared to historical controls receiving a secondary would closure.
Time Frame
Up to 3 months after surgery
Title
Proportion of Patients Returning after Surgery
Description
The proportion of patients that return within 30 days of surgery.
Time Frame
Up to 30 days after surgery
Title
Change of Quality of Life Questionnaire SF-36
Description
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.
Time Frame
Up to 3 months after tertiary wound closure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G Kelly, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
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