Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds

NCT02559453 | Unknown

• 1 other identifier: 121012014
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

• Number of post-hospital discharge complications between subjects who received 2 versus 3 or more debridement operations prior to closure.

  180 Days

Study Arms (2)

2 operations

ACTIVE COMPARATOR

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

Procedure: Debridement

3 or more operations

ACTIVE COMPARATOR

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

Procedure: Debridement

Interventions

Debridement PROCEDURE

Removing dead tissue from infected wounds.

2 operations; 3 or more operations

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

MeSH Terms

Conditions

Wound Infection

Interventions

Debridement

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Christopher Attinger, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Wound Healing

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 24, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share