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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Incision

Intervention / Treatment
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* Procedure: Tertiary Wound Closure
* Procedure: Historical Wound Closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tertiary Wound Closure<br>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. | Procedure: Tertiary Wound Closure<br>* 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.<br>|
| Active Comparator: Historical Wound Closure<br>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). | Procedure: Historical Wound Closure<br>* Participants wounds are left partially open to heal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Proportion of Patients Returning after Surgery | The proportion of patients that return within 30 days of surgery. | Up to 30 days after 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. | Up to 3 months after tertiary wound closure |