Surgical Site Infection Rate After Intra-Abdominal Surgery Using Negative Pressure Wound Therapy at Initial Closure

NCT01924884 | Completed

• 2 other identifiers: IRB00155110NA_00052186
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to present a large single-institution experience reporting surgical site infection rates in patients who have undergone intra-abdominal surgery followed by wound closure with Negative Pressure Wound Therapy. A retrospective review of patients' charts will be conducted to analyze surgical site infection rates between wound closure with and without Negative Pressure Wound Therapy (NPWT). American College of Surgeons National Quality Improvement Program data from previous standard of care (primary closure after colorectal surgery) will be used for comparison with newly adopted standard of care treatment regimen (wound closure with NPWT). Data on patients who underwent intra-abdominal surgery will be retrospectively collected and a database will be created. These individuals will be identified through medical records and recontacted by mail and/or phone to collect study data. Finally, patients newly referred to the Principal Investigator for intra-abdominal surgery will be enrolled in the database. After giving informed consent, data on surgical site infection rates and outcomes will be collected. Longitudinal outcomes will be assessed at 30 days, 6 months, and 12 months post-operatively. These patients' outcomes will be compared to a group of patients treated by the Principal Investigator who also underwent intra-abdominal surgery without Negative Pressure Wound Therapy. We hypothesize that fewer patients treated with negative pressure wound therapy following intra-abdominal surgery will develop surgical site infections than patients who had intra-abdominal surgery but were not treated with Negative Pressure Wound Therapy.

Conditions

Surgical Wound Infection; Wound; Abdomen, Abdominal Wall; Surgery

Keywords

Vacuum-Assisted Closure; Topical Negative-Pressure Therapy; Negative-Pressure Dressings

Outcome Measures

Primary Outcomes (1)

• Surgical site infection (per the 1999 Guideline for Prevention of Surgical Site Infection from the Hospital Infections Program at the National Center for Infectious Diseases, Centers for Disease Control and Prevention).

  Comparing surgical site infection (per the 1999 Guideline for Prevention of Surgical Site Infection from the Hospital Infections Program at the National Center for Infectious Diseases) rates between patients treated with and without negative pressure wound therapy. Objective: To determine if a newly adopted standard of care \[negative pressure wound therapy (NPWT)\] for clean, clean-contaminated, and contaminated wounds will lead to decreased rates of post-operative surgical site infection.

  Up to one year

Secondary Outcomes (2)

• Surgical site occurrence (per the 2010 Ventral Hernia Working Group's classification and the modified hernia grading scale by Kanters et al.; 2012).

  Up to one year

• Quantifying post-operative morbidity and mortality rates among patients undergoing bowel surgery with or without negative pressure wound therapy.

  Up to one year

Other Outcomes (1)

• Quantifying post-operative morbidity and mortality rates among patients undergoing enterocutaneous fistula and ventral hernia repair with or without negative pressure wound therapy.

  Up to one year

Study Arms (4)

Prospective

Patients newly referred to the Principal Investigator for intra-abdominal surgery and for whom the Principal Investigator anticipates using Negative-Pressure Wound Therapy.

Retrospective

Patients who underwent intra-abdominal surgery by the Principal Investigator between January 1, 2011 and May 9, 2013 will be identified through patient medical records. Living patients will be contacted via letter from the Principal Investigator introducing the study along with the study's consent form for the patients' review. Interested patients will be consented either in person at the patient's next clinic visit or via telephone by a member of the study staff.

Historical Controls

Patients who underwent intra-abdominal surgery without Negative-Pressure Wound Therapy by the Principal Investigator prior to January 1, 2011 will be enrolled as Historical Controls.

De-Identified Retrospective

Patients who underwent intra-abdominal surgery by the Principal Investigator between January 1, 2011 and May 9, 2013 and are deceased or do not consent to be in the study will be enrolled in the De-Identified Retrospective Case Cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients greater than or equal to 18 years of age undergoing intra-abdominal surgery at Johns Hopkins Hospital by Dr. Frederic Eckhauser. Both men and women and members of all races and ethnic groups are eligible.

You may qualify if:

• Greater than or equal to 18 years of age
• Undergoing intra-abdominal surgery at Johns Hopkins Hospital by Dr. Frederic Eckhauser

You may not qualify if:

• Less than 18 years of age
• Pregnant females

Sponsors & Collaborators

• Johns Hopkins University: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection; Wounds and Injuries

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carisa Cooney, MPH, CCRP

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 19, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)