Pressure SoresNCT06243328
Effect of Negative Wound Pressure on P.S
A study testing negative wound pressure therapy in people with Pressure Sores, run by Assiut University.
Trial summary
This study will compare the NPWT using the NPD to the conventional wound dressing and specifically evaluating (i) reduction of wound surface area and depth, (ii) removal of slough and formation of granulation tissue Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Sores
- What is being tested?
- negative wound pressure therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stages three and four PU as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
Who cannot join
- wound with necrotic tissue unlikely to tolerate debridement. Exposed Vessels, Nerves and or organs. Active bleeding. Ischemic limb. Opening into body cavity
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomised Clinical Trial of the Negative Pressure Wound Therapy Versus Conventional Dressing for Pressure Ulcers Management
This study will compare the NPWT using the NPD to the conventional wound dressing and specifically evaluating (i) reduction of wound surface area and depth, (ii) removal of slough and formation of granulation tissue
Read the detailed description
Initial debridement of slough and necrotic tissue was performed in all patients at the time of admission and before their being allocated in a group.
it's 3 groups:
Group (A): conventional dressing :
acting by:preventing pus, the findings from the review indicate that decreasing frictional forces transmitted to the patient's skin is achieved by use of a dressing with an outer surface made from a low friction material.
The surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound. Dressing changes will be performed once or twice daily depending on the soakage of the dressing.
.
Group (B), negative pressure wound therapy using the electronic-vac :
It is believed that the negative pressure assists in removal of interstitial fluid, decreasing oedema, increasing blood flow and reducing tissue bacterial levels, in addition, mechanical deformation of cells is thought to result in protein and matrix molecule synthesis, which increases the rate of cell proliferation and granulation tissue formation, this , in turn , may promote healing .
We will place a nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape. The dressing will be connected to the machine through tubing that was connected to the canister. Continuous pressure of 200 mm Hg will be applied. The dressing will be changed three times a week Group (C), negative pressure wound therapy using the Romo-vac: The NPD will be applied as a bedside procedure with a low-power continuous suction apparatus. We will Place nonadherent contact layer, such as Xeroform between prepared wound bed and contact dressing with sealling using an adhesive drape. The dressing will be connected to the Romo-vac which applying pressure of-60 to -125 mm Hg. The Romo-vac will be recharged every 5-6 hours and the dressing will be changed three times a week or earlier if there is a soakage/leakage
- Conditions
- Pressure Sores
- Being tested
- negative wound pressure therapy
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
negative wound pressure therapyDevice
nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape. The dressing will be connected to the machine through tubing that was connected to the canister
| Study group | Role | What they receive |
|---|---|---|
| conventional dressing | Experimental | The surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound. Dressing changes will be performed once or twice daily depending on the soakage of the dressing Receives: Device: negative wound pressure therapy |
| negative pressure wound therapy | Experimental | We will place a nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape. The dressing will be connected to the machine through tubing that was connected to the canister. Continuous pressure of 200 mm Hg will be applied. The dressing will be changed three times a week. Receives: Device: negative wound pressure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcer size
measured for its greatest length ,depth and width with flexigrid Opsite.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pressure SoresStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, issraa Aly, Assiut University
- Investigators
- assem hussien, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243328
- Sponsor's protocol ID
- VAC on PS
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Avsar P, Moore Z, Patton D. Dressings for preventing pressure ulcers: how do they work? J Wound Care. 2021 Jan 2;30(1):33-39. doi: 10.12968/jowc.2021.30.1.33.
PubMed 33439083Srivastava RN, Dwivedi MK, Bhagat AK, Raj S, Agarwal R, Chandra A. A non-randomised, controlled clinical trial of an innovative device for negative pressure wound therapy of pressure ulcers in traumatic paraplegia patients. Int Wound J. 2016 Jun;13(3):343-8. doi: 10.1111/iwj.12309. Epub 2014 Jun 3.
PubMed 24894079Lesiak AC, Shafritz AB. Negative-pressure wound therapy. J Hand Surg Am. 2013 Sep;38(9):1828-32. doi: 10.1016/j.jhsa.2013.04.029. Epub 2013 Jun 25. No abstract available.
PubMed 23809469
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial of the Negative Pressure Wound Therapy Versus Conventional Dressing for Pressure Ulcers Management
- ClinicalTrials.gov ID
- NCT06243328
- Acronym / sponsor ID
- VAC on PS
- Conditions
- Pressure Sores
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Feb 2024 (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.
This study will compare the NPWT using the NPD to the conventional wound dressing and specifically evaluating (i) reduction of wound surface area and depth, (ii) removal of slough and formation of granulation tissue
Detailed description
Initial debridement of slough and necrotic tissue was performed in all patients at the time of admission and before their being allocated in a group.
it's 3 groups:
Group (A): conventional dressing :
acting by:preventing pus, the findings from the review indicate that decreasing frictional forces transmitted to the patient's skin is achieved by use of a dressing with an outer surface made from a low friction material.
The surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound. Dressing changes will be performed once or twice daily depending on the soakage of the dressing.
.
Group (B), negative pressure wound therapy using the electronic-vac :
It is believed that the negative pressure assists in removal of interstitial fluid, decreasing oedema, increasing blood flow and reducing tissue bacterial levels, in addition, mechanical deformation of cells is thought to result in protein and matrix molecule synthesis, which increases the rate of cell proliferation and granulation tissue formation, this , in turn , may promote healing .
We will place a nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape. The dressing will be connected to the machine through tubing that was connected to the canister. Continuous pressure of 200 mm Hg will be applied. The dressing will be changed three times a week Group (C), negative pressure wound therapy using the Romo-vac: The NPD will be applied as a bedside procedure with a low-power continuous suction apparatus. We will Place nonadherent contact layer, such as Xeroform between prepared wound bed and contact dressing with sealling using an adhesive drape. The dressing will be connected to the Romo-vac which applying pressure of-60 to -125 mm Hg. The Romo-vac will be recharged every 5-6 hours and the dressing will be changed three times a week or earlier if there is a soakage/leakage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional dressing | Experimental | Device: negative wound pressure therapyThe surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound. Dressing changes will be performed once or twice daily depending on the soakage of the dressing |
| negative pressure wound therapy | Experimental | Device: negative wound pressure therapyWe will place a nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape. The dressing will be connected to the machine through tubing that was connected to the canister. Continuous pressure of 200 mm Hg will be applied. The dressing will be changed three times a week. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Stages three and four PU as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
Key exclusion criteria (1 listed)
- wound with necrotic tissue unlikely to tolerate debridement. Exposed Vessels, Nerves and or organs. Active bleeding. Ischemic limb. Opening into body cavity
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 |
|---|---|---|
| negative wound pressure therapynonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape. The dressing will be connected to the machine through tubing that was connected to the canister | Device | conventional dressing, negative pressure wound therapy |
Primary outcome
ulcer size
Time frame: 3 weeks
measured for its greatest length ,depth and width with flexigrid Opsite.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 33439083Avsar P, Moore Z, Patton D. Dressings for preventing pressure ulcers: how do they work? J Wound Care. 2021 Jan 2;30(1):33-39. doi: 10.12968/jowc.2021.30.1.33.
- Background: PubMed 24894079Srivastava RN, Dwivedi MK, Bhagat AK, Raj S, Agarwal R, Chandra A. A non-randomised, controlled clinical trial of an innovative device for negative pressure wound therapy of pressure ulcers in traumatic paraplegia patients. Int Wound J. 2016 Jun;13(3):343-8. doi: 10.1111/iwj.12309. Epub 2014 Jun 3.
- Background: PubMed 23809469Lesiak AC, Shafritz AB. Negative-pressure wound therapy. J Hand Surg Am. 2013 Sep;38(9):1828-32. doi: 10.1016/j.jhsa.2013.04.029. Epub 2013 Jun 25. No abstract available.
Related trials for Pressure Sores
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
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.
assem hussien, professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing negative wound pressure therapy in people with Pressure Sores, run by Assiut 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 1 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 6 Feb 2024. 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?
Contact issraa aly mohamed, resident doctor (01097426746, issraaaly96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ulcer size (time frame: 3 weeks). 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 NCT06243328, which also lists 3 linked publications.
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 6 Feb 2024.