Post Traumatic Skin LossNCT05653297
Negative Pressure Wound Therapy in Traumatic Skin Loss
An observational study of Post Traumatic Skin Loss, run by Assiut University.
Trial summary
Assessment of the effectiveness of negative pressure wound therapy on post-traumatic wounds, as regard to : The period of granulation tissue formation. The infection rate in NPWT in comparison to conventional dressing. The rate of graft take after NPWT. The length of hospital stay. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Traumatic Skin Loss
- What is being tested?
- Vacuum-Assisted Closure
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Jun 2024
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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
Study population: Post Traumatic Patients with skin \& soft tissue loss with no contraindication to use of VAC
Who may be able to join
- No age preference.
- No gender preference.
- Acute traumatic wounds.
- Admitted to the hospital.
Who cannot join
- Exposed Vessels, Nerves \& Organs.
- Active bleeding.
- Ischemic limb.
- Opening into body cavity.
- Vulnerable body organs.
- Necrotic tissue with eschar present.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Study of The Use of Negative Pressure Wound Therapy in Traumatic Skin & Soft Tissue Loss
Assessment of the effectiveness of negative pressure wound therapy on post-traumatic wounds, as regard to :
- The period of granulation tissue formation.
- The infection rate in NPWT in comparison to conventional dressing.
- The rate of graft take after NPWT.
- The length of hospital stay.
Read the detailed description
Over the last 15 years, negative-pressure wound therapy "NPWT" has become commonly used for treatment of a wide variety of complex wounds. Many clinicians have noted a dramatic response when negative-pressure wound therapy technology has been used, prompting a number of scientific investigations related to its mechanism of action and clinical trials determining its efficacy.
NPWT is a modality that has shown great promise and delivered significantly better results in the clinical care of acute as well as chronic wounds. It is designed to seal the wound site using foam dressing linked to an electronic pump, which applies a pressure ranging from -75 to -150 mmHg. As a matter of fact, NPWT's impact on wound healing appears to be the consequence of multiple effects, each contributing to the overall positive influence on wound healing. Current research indicates that there are four primary NPWT mechanisms of action: Macrodeformation, Microdeformation, Fluid removal and Environmental control of the wound.
Even if the role of NPWT in promoting wound healing has been largely accepted, there is a lack of evidence (few high-level clinical studies) regarding its effectiveness and further research is needed to better understand the mechanisms of action.
Traumatic wounds vary from abrasions and minor skin incisions or tears to wounds with extensive tissue damage or loss and damage to bone and internal organs. Delayed wound healing particularly in difficult wounds is a major concern, It leads to pain, morbidity, prolonged treatment, and require major reconstructive surgery which imposes enormous social and financial burden.
- Conditions
- Post Traumatic Skin Loss
- Being tested
- Vacuum-Assisted Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-Assisted ClosureDevice
NPWT (MEDWAY GROUP VAC) will be applied on post traumatic raw areas until the wound is ready for reconstruction, Then it will be applied over skin graft after coverage
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control Group) | will undergo conventional dressing daily until the wound is ready for reconstruction, Then coverage of the wound with conventional tie over for 4 days. | |
| Group B (Experimental Group) | NPWT (MEDWAY GROUP VAC) will be applied on a continuous mode between -75 \& -150 mm Hg for 4 days per session for indefinite number of sessions until the wound is ready for reconstruction, Then it will be applied after coverage of the wound for 1 session. Receives: Device: Vacuum-Assisted Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Granulation tissue formation
Healthy granulation tissue appears pink to red due to new capillary formation, soft to touch, moist appears "bumpy," and typically painless.
Measured: 2 weeks
Graft Take
The graft take assessment by clinical examination
Measured: 4 days after coverage
Secondary outcomes (1)
Length of hospital stay
Duration of hospital stay since time of trauma till discharge from hospital after coverage of the wound.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Skin LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Philip Ryad Gadelsayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653297
- Sponsor's protocol ID
- NPWT In Traumatic Wounds
- Status last verified
- Dec 2022
- First submitted
- 27 Nov 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Orgill DP, Bayer LR. Update on negative-pressure wound therapy. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:105S-115S. doi: 10.1097/PRS.0b013e318200a427.
PubMed 21200280Bellot GL, Dong X, Lahiri A, Sebastin SJ, Batinic-Haberle I, Pervaiz S, Puhaindran ME. MnSOD is implicated in accelerated wound healing upon Negative Pressure Wound Therapy (NPWT): A case in point for MnSOD mimetics as adjuvants for wound management. Redox Biol. 2019 Jan;20:307-320. doi: 10.1016/j.redox.2018.10.014. Epub 2018 Oct 23.
PubMed 30390545Peinemann F, Sauerland S. Negative-pressure wound therapy: systematic review of randomized controlled trials. Dtsch Arztebl Int. 2011 Jun;108(22):381-9. doi: 10.3238/arztebl.2011.0381. Epub 2011 Jun 3.
PubMed 21712971Pappalardo V, Frattini F, Ardita V, Rausei S. Negative Pressure Therapy (NPWT) for Management of Surgical Wounds: Effects on Wound Healing and Analysis of Devices Evolution. Surg Technol Int. 2019 May 15;34:56-67.
PubMed 31034574El-den S, Reizian A, Yahia A, Zedan A, Shormana M. Effect of Negative Pressure Wound Therapy on Post-traumatic Wound Healing. International Journal of Novel Research in Healthcare and Nursing. 2021;7(3):590-608.
Agarwal P, Kukrele R, Sharma D. Vacuum assisted closure (VAC)/negative pressure wound therapy (NPWT) for difficult wounds: A review. J Clin Orthop Trauma. 2019 Sep-Oct;10(5):845-848. doi: 10.1016/j.jcot.2019.06.015. Epub 2019 Jun 20.
PubMed 31528055
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of The Use of Negative Pressure Wound Therapy in Traumatic Skin & Soft Tissue Loss
- ClinicalTrials.gov ID
- NCT05653297
- Acronym / sponsor ID
- NPWT In Traumatic Wounds
- Conditions
- Post Traumatic Skin Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 16 Dec 2022 (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.
Assessment of the effectiveness of negative pressure wound therapy on post-traumatic wounds, as regard to :
- The period of granulation tissue formation.
- The infection rate in NPWT in comparison to conventional dressing.
- The rate of graft take after NPWT.
- The length of hospital stay.
Detailed description
Over the last 15 years, negative-pressure wound therapy "NPWT" has become commonly used for treatment of a wide variety of complex wounds. Many clinicians have noted a dramatic response when negative-pressure wound therapy technology has been used, prompting a number of scientific investigations related to its mechanism of action and clinical trials determining its efficacy.
NPWT is a modality that has shown great promise and delivered significantly better results in the clinical care of acute as well as chronic wounds. It is designed to seal the wound site using foam dressing linked to an electronic pump, which applies a pressure ranging from -75 to -150 mmHg. As a matter of fact, NPWT's impact on wound healing appears to be the consequence of multiple effects, each contributing to the overall positive influence on wound healing. Current research indicates that there are four primary NPWT mechanisms of action: Macrodeformation, Microdeformation, Fluid removal and Environmental control of the wound.
Even if the role of NPWT in promoting wound healing has been largely accepted, there is a lack of evidence (few high-level clinical studies) regarding its effectiveness and further research is needed to better understand the mechanisms of action.
Traumatic wounds vary from abrasions and minor skin incisions or tears to wounds with extensive tissue damage or loss and damage to bone and internal organs. Delayed wound healing particularly in difficult wounds is a major concern, It leads to pain, morbidity, prolonged treatment, and require major reconstructive surgery which imposes enormous social and financial burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group) | – | –will undergo conventional dressing daily until the wound is ready for reconstruction, Then coverage of the wound with conventional tie over for 4 days. |
| Group B (Experimental Group) | – | Device: Vacuum-Assisted ClosureNPWT (MEDWAY GROUP VAC) will be applied on a continuous mode between -75 \& -150 mm Hg for 4 days per session for indefinite number of sessions until the wound is ready for reconstruction, Then it will be applied after coverage of the wound for 1 session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Post Traumatic Patients with skin \& soft tissue loss with no contraindication to use of VAC
Key inclusion criteria (4 listed)
- No age preference.
- No gender preference.
- Acute traumatic wounds.
- Admitted to the hospital.
Key exclusion criteria (6 listed)
- Exposed Vessels, Nerves \& Organs.
- Active bleeding.
- Ischemic limb.
- Opening into body cavity.
- Vulnerable body organs.
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 |
|---|---|---|
| Vacuum-Assisted ClosureNPWT (MEDWAY GROUP VAC) will be applied on post traumatic raw areas until the wound is ready for reconstruction, Then it will be applied over skin graft after coverage | Device | Group B (Experimental Group) |
Primary outcome
Granulation tissue formation
Time frame: 2 weeks
Healthy granulation tissue appears pink to red due to new capillary formation, soft to touch, moist appears "bumpy," and typically painless.
Graft Take
Time frame: 4 days after coverage
The graft take assessment by clinical examination
1 secondary outcome
Length of hospital stay
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Background: PubMed 21200280Orgill DP, Bayer LR. Update on negative-pressure wound therapy. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:105S-115S. doi: 10.1097/PRS.0b013e318200a427.
- Background: PubMed 30390545Bellot GL, Dong X, Lahiri A, Sebastin SJ, Batinic-Haberle I, Pervaiz S, Puhaindran ME. MnSOD is implicated in accelerated wound healing upon Negative Pressure Wound Therapy (NPWT): A case in point for MnSOD mimetics as adjuvants for wound management. Redox Biol. 2019 Jan;20:307-320. doi: 10.1016/j.redox.2018.10.014. Epub 2018 Oct 23.
- Background: PubMed 21712971Peinemann F, Sauerland S. Negative-pressure wound therapy: systematic review of randomized controlled trials. Dtsch Arztebl Int. 2011 Jun;108(22):381-9. doi: 10.3238/arztebl.2011.0381. Epub 2011 Jun 3.
- Background: PubMed 31034574Pappalardo V, Frattini F, Ardita V, Rausei S. Negative Pressure Therapy (NPWT) for Management of Surgical Wounds: Effects on Wound Healing and Analysis of Devices Evolution. Surg Technol Int. 2019 May 15;34:56-67.
- BackgroundEl-den S, Reizian A, Yahia A, Zedan A, Shormana M. Effect of Negative Pressure Wound Therapy on Post-traumatic Wound Healing. International Journal of Novel Research in Healthcare and Nursing. 2021;7(3):590-608.
- Background: PubMed 31528055Agarwal P, Kukrele R, Sharma D. Vacuum assisted closure (VAC)/negative pressure wound therapy (NPWT) for difficult wounds: A review. J Clin Orthop Trauma. 2019 Sep-Oct;10(5):845-848. doi: 10.1016/j.jcot.2019.06.015. Epub 2019 Jun 20.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Skin Loss, 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 4 inclusion and 6 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 16 Dec 2022. 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 David Ph Ryad, Resident (01064388822, dr.davidphilip1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Granulation tissue formation (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 NCT05653297, which also lists 6 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 16 Dec 2022.