Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds

A Randomized Trial Comparing the Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds Requiring Hospitalization

We have designed this study to determine whether performing two, compared with ≥3 operations has an effect on key clinical outcomes after discharge from the hospital of an infected wound that requires admission. Each arm of this study represents the two commonly practiced standard of care treatment plans for patients presenting with infected wounds. It is currently unknown which SoC option provides the best patient outcome.

Study Overview

• Status: Unknown
• Conditions: Wound Infection
• Intervention / Treatment: Procedure: Debridement

Detailed Description

There is a lack of consensus about whether or not a patient with an infected wound requires more than 2 surgical procedures. For patients admitted for an infected wound this study will investigate whether 2, compared with ≥3, operative interventions results in better outcomes. All patients admitted for an infected wound will be assessed for eligibility in the study. If eligible, subjects will be randomized into Cohort A (2 operative visits) or Cohort B (≥3 operative visits). Subjects will then be followed during the hospitalization as well as 180 days post discharge.

A total of 250 subjects will be enrolled into this study. Two operations (n=125) will be compared with ≥3 operations (n=125) during the hospitalization. We will compare the following factors between the two treatment groups: length of hospital stay; readmission post-discharge; quality of life; proportion of wounds closed or covered with a graft; culture results; host factors; environmental factors post-hospital discharge; and, financial charges related to admission and readmission. We expect full enrollment to take 3 years in duration.

Debridement of the wound will be performed in the customary manner per SOC in the operating room. Prior to the start of the study, the surgeons performing the operations will be required to view a video that demonstrates the standardized debridement technique that will be utilized. The following is the standardized technique depicted in the video:

All wound surfaces will be painted with dye prior to debridement. Debridement involves the use of a scalpel, scissors, curette, rongeur, or hydro-surgery. A 2-3 millimeter skin edge around the perimeter of the wound will also be resected. All infected/nonviable tissue will be removed and all tissues with dye will be surgically removed. This includes decompression of any purulent material and excision of any indurated tissue (until tissue pliability is established). Nonviable tissue includes necrotic and fibrous tissue. Debridement will be performed until the there is bleeding on the wound base and perimeter.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infected wound requiring hospital admission
• Infected wound requiring an operative intervention
• Wound can be located anywhere on the body
• Patient able and willing to comply with all study requirements

Exclusion Criteria:

• Planned free tissue flap for soft tissue reconstruction
• Wound located over exposed joint implant
• Wound located over exposed hardware
• Disease or treatment causing substantial immunosuppression
• History of collagen vascular disease
• Transplant recipient
• Venous stasis ulcer
• Radiation-induced ulcer
• Contraindication for use of negative pressure wound therapy with instillation of normal saline
• Unable or unwilling to comply with study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2 operations; Subjects in this arm will receive a maximum of two surgical debridements of their wound.	Procedure: Debridement; Removing dead tissue from infected wounds.
Active Comparator: 3 or more operations; Subjects in this arm will receive three or more surgical debridements of their wound.	Procedure: Debridement; Removing dead tissue from infected wounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of post-hospital discharge complications between subjects who received 2 versus 3 or more debridement operations prior to closure.	180 Days

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: Christopher Attinger, MD, MedStar Georgetown University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (Estimate): September 24, 2015

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: 121012014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data was not collected for use in future research and will not be shared.