Necrotizing FascitisNCT05883033
VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis
A study testing VAC in people with Necrotizing Fascitis, run by Assiut University at 1 site in Egypt.
Trial summary
Find out the best management of Necrotizing Fasciitis after surgical debridement Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Necrotizing Fascitis
- What is being tested?
- VAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 30 Apr 2024
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Immunocompromised patients such as; diabetic, HIV and leukaemia.
- And other chronic debilitating diseases.
Who cannot join
- Necrotizing Fasciitis of Head and neck and upper limbs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Vacuum Assisted Closure (VAC) and Conventional Dressing in the Healing Process of Necrotizing Fasciitis After Surgical Debridement.. Clinical and Laboratory Study.
Find out the best management of Necrotizing Fasciitis after surgical debridement
Read the detailed description
Necrotizing fasciitis is a life-threatening condition that can occur as a result of trauma or foreign bodies in surgical wounds as well as idiopathically. Necrotizing fasciitis is characterized by a progressive infection in fascial planes with necrosis of the subcutaneous tissue. Necrotizing fasciitis affects the extremities more frequently than central areas. Risk factors for necrotizing fasciitis include diabetes mellitus, trauma wound infections, decubitus ulcers, alcoholism, carcinoma, peripheral vascular disease, smoking, and intravenous drug abuse. A varieties of micro-organisms, including gram-positive group A streptococcus, haemolytic streptococci, and staphylococcus aureus; gram-negative Enterobacteriaceae, Escherichia coli, Klebsiella spp., and Proteus spp.; anaerobes including Peptostreptococcus, Clostridium, and Pacteroides; and fungi such as Candida and acid-fast bacteria have all been implicated in the pathogenesis of Necrotizing fasciitis.
Necrotizing fasciitis is a surgical emergency for detoxification by debridement with good antibiotic coverage. It has mortality rate reaching 20-30% , this mortality rate is high and requires prompt diagnosis, antibiotic treatment and extensive necrosectomy up to intensive care units admission in some cases, the aim of our prospective analysis is to assess with a hypothesis-generating and exploratory purpose the possible role of VAC versus ordinary dressings in the wound therapy of Necrotizing Fasciitis in terms of expected time for wound closure and survival rate.
- Conditions
- Necrotizing Fascitis
- Being tested
- VAC
- Medical subject headings
- Fasciitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VACDevice
Vacuum Assisted Closure device
| Study group | Role | What they receive |
|---|---|---|
| Vacuum Assisted Closure device | Experimental | Vacuum Assisted Closure device for healing enhancement Receives: Device: VAC |
| Conventional dressing | Experimental | Unprocessed Honey, malysia glycerine and betadine ointment Receives: Device: VAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital staying length
the difference in hospital stay length between patients with necrotizing fasciitis who received conventional management versus those treated with vacuum-assisted closure. A systematic review showed a significant difference between the two methods
Measured: Baseline
Secondary outcomes (2)
Required other stages of debridement
Comparison in the other stages of debridement required in both methods
Measured: Baseline
Expected closure of the wound by secondary intention
The difference in expected time required for closure of the wound by secondary intention between patients with necrotizing fasciitis who received conventional management versus those treated with vacuum-assisted closure.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotizing FascitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Youhana Saba, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883033
- Sponsor's protocol ID
- Necrotizing fasciitis
- Status last verified
- May 2023
- First submitted
- 22 Apr 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang R, Zhang Y, Hou L, Yan C. Vacuum-assisted closure versus conventional dressing in necrotizing fasciitis: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Feb 4;18(1):85. doi: 10.1186/s13018-023-03561-7.
PubMed 36737764
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Vacuum Assisted Closure (VAC) and Conventional Dressing in the Healing Process of Necrotizing Fasciitis After Surgical Debridement.. Clinical and Laboratory Study.
- ClinicalTrials.gov ID
- NCT05883033
- Acronym / sponsor ID
- Necrotizing fasciitis
- Conditions
- Necrotizing Fascitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 31 May 2023 (actual)
- 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.
Find out the best management of Necrotizing Fasciitis after surgical debridement
Detailed description
Necrotizing fasciitis is a life-threatening condition that can occur as a result of trauma or foreign bodies in surgical wounds as well as idiopathically. Necrotizing fasciitis is characterized by a progressive infection in fascial planes with necrosis of the subcutaneous tissue. Necrotizing fasciitis affects the extremities more frequently than central areas. Risk factors for necrotizing fasciitis include diabetes mellitus, trauma wound infections, decubitus ulcers, alcoholism, carcinoma, peripheral vascular disease, smoking, and intravenous drug abuse. A varieties of micro-organisms, including gram-positive group A streptococcus, haemolytic streptococci, and staphylococcus aureus; gram-negative Enterobacteriaceae, Escherichia coli, Klebsiella spp., and Proteus spp.; anaerobes including Peptostreptococcus, Clostridium, and Pacteroides; and fungi such as Candida and acid-fast bacteria have all been implicated in the pathogenesis of Necrotizing fasciitis.
Necrotizing fasciitis is a surgical emergency for detoxification by debridement with good antibiotic coverage. It has mortality rate reaching 20-30% , this mortality rate is high and requires prompt diagnosis, antibiotic treatment and extensive necrosectomy up to intensive care units admission in some cases, the aim of our prospective analysis is to assess with a hypothesis-generating and exploratory purpose the possible role of VAC versus ordinary dressings in the wound therapy of Necrotizing Fasciitis in terms of expected time for wound closure and survival rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum Assisted Closure device | Experimental | Device: VACVacuum Assisted Closure device for healing enhancement |
| Conventional dressing | Experimental | Device: VACUnprocessed Honey, malysia glycerine and betadine ointment |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Immunocompromised patients such as; diabetic, HIV and leukaemia.
- And other chronic debilitating diseases.
Key exclusion criteria (1 listed)
- Necrotizing Fasciitis of Head and neck and upper limbs.
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 |
|---|---|---|
| VACVacuum Assisted Closure device | Device | Conventional dressing, Vacuum Assisted Closure device |
Primary outcome
Hospital staying length
Time frame: Baseline
the difference in hospital stay length between patients with necrotizing fasciitis who received conventional management versus those treated with vacuum-assisted closure. A systematic review showed a significant difference between the two methods
2 secondary outcomes
Required other stages of debridement
Time frame: Baseline
Expected closure of the wound by secondary intention
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Background: PubMed 36737764Zhang R, Zhang Y, Hou L, Yan C. Vacuum-assisted closure versus conventional dressing in necrotizing fasciitis: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Feb 4;18(1):85. doi: 10.1186/s13018-023-03561-7.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAC in people with Necrotizing Fascitis, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 1 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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Mario Saba, BMMS (+201091196224, mario_saba_417@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital staying length (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883033, which also lists 1 linked publication.
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 31 May 2023.