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

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.

Study Overview

• Status: Terminated
• Conditions: Surgical Incision
• Intervention / Treatment: Procedure: Tertiary Wound Closure; Procedure: Historical Wound Closure

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tertiary Wound Closure; 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; 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.
Active Comparator: Historical Wound Closure; 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; Participants wounds are left partially open to heal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Wound Closures Comparing Tertiary Wound Closure Versus Historical Controls Postoperative Day 30	The number of surgical wounds that remained closed at 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
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
Number of Participants With Surgical Site Infections (SSI) for Tertiary Technique Versus Historical Controls	The number of Surgical Site Infections (SSI) within 30 days using a tertiary closure technique compared to historical controls receiving a secondary would closure.	30 days after tertiary wound closure
Proportion of Patients Returning After Surgery	The proportion of patients that return to hospital within 30 days of surgery.	Up to 30 days after surgery
Quality of Life Questionnaire SF-36 (Version 1)	The quality of life is estimated only in patients receiving a tertiary wound closure. Groups of questions were transformed into a 0-100 scale for eight domains. 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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michael G Kelly, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): November 26, 2020
• Study Completion (Actual): November 26, 2020

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: IRB00055298; P30CA012197 (U.S. NIH Grant/Contract); NCI-2019-01292 (Other Identifier: National Cancer Institute); CCCWFU04418 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No