Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds

NCT ID: NCT02559453

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-06-30

Brief Summary

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.

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.

Conditions

Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

2 operations

Subjects in this arm will receive a maximum of two surgical debridements of their wound.

Group Type: ACTIVE_COMPARATOR

Debridement

Intervention Type: PROCEDURE

Removing dead tissue from infected wounds.

3 or more operations

Subjects in this arm will receive three or more surgical debridements of their wound.

Group Type: ACTIVE_COMPARATOR

Debridement

Intervention Type: PROCEDURE

Removing dead tissue from infected wounds.

Interventions

Debridement

Removing dead tissue from infected wounds.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Attinger, M.D.

Director of the Center for Wound Healing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Attinger, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Georgetown University Hospital

Other Identifiers

121012014

Identifier Type: -

Identifier Source: org_study_id