Wound InfectionNCT02559453
Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds
A study testing Debridement in people with Wound Infection, run by Georgetown University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound Infection
- What is being tested?
- Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- Debridement
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DebridementProcedure or surgery
Removing dead tissue from infected wounds.
| Study group | Role | What they receive |
|---|---|---|
| 2 operations | Active comparator | Subjects in this arm will receive a maximum of two surgical debridements of their wound. Receives: Procedure: Debridement |
| 3 or more operations | Active comparator | Subjects in this arm will receive three or more surgical debridements of their wound. Receives: Procedure: Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of post-hospital discharge complications between subjects who received 2 versus 3 or more debridement operations prior to closure.
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Attinger, M.D., Georgetown University
- Investigators
- Christopher Attinger, MD, Principal investigator, MedStar Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559453
- Sponsor's protocol ID
- 121012014
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2015
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data was not collected for use in future research and will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds Requiring Hospitalization
- ClinicalTrials.gov ID
- NCT02559453
- Acronym / sponsor ID
- 121012014
- Conditions
- Wound Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 operations | Active comparator | Procedure: DebridementSubjects in this arm will receive a maximum of two surgical debridements of their wound. |
| 3 or more operations | Active comparator | Procedure: DebridementSubjects in this arm will receive three or more surgical debridements of their wound. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DebridementRemoving dead tissue from infected wounds. | Procedure or surgery | 2 operations, 3 or more operations |
Primary outcome
Number of post-hospital discharge complications between subjects who received 2 versus 3 or more debridement operations prior to closure.
Time frame: 180 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: No. Data was not collected for use in future research and will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Attinger, MD principal investigator
MedStar Georgetown University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Debridement in people with Wound Infection, run by Georgetown University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of post-hospital discharge complications between subjects who received 2 versus 3 or more debridement operations prior to closure. (time frame: 180 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.