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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-27

Study Completion Date

2020-11-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Risk Factors for Development of Incisional Hernia in Transverse Incisions

NCT03561727

Incisional Hernia Malignancy

UNKNOWN NA

Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery

NCT00107627

Cancer

COMPLETED PHASE3

Evaluation of Purse-String Closure Vs Second Intention

NCT02062866

Wound Closure Techniques

COMPLETED NA

A Study to Evaluate a Quality Improvement Intervention to Reduce Wound Separation Rates in Obese Gynecologic Oncology Service Patients Undergoing Abdominal Surgery

NCT02071251

Wound Complications Wound Infection Wound Separation

COMPLETED PHASE2

Effect of Skin Closure Techniques on Body Image in Women Undergoing Gynecologic Surgery

NCT07327125

Gynecologic Cancers Surgical Wound Closure Techniques Body Image

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Incision

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Tertiary Wound Closure

Intervention Type PROCEDURE

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

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").

Group Type ACTIVE_COMPARATOR

Historical Wound Closure

Intervention Type PROCEDURE

Participants wounds are left partially open to heal.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Historical Wound Closure

Participants wounds are left partially open to heal.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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