WoundsNCT03521258
Limb Salvage Through Tissue Engineering: A Novel Treatment Modality Using Dehydrated Human Amnion/Chorion Membrane
A study testing Dehydrated Human Amnion/Chorion Membrane and Flap-Based Reconstructive Surgery in people with Wounds and Trauma, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
Extremity wounds with exposed critical structures, including bone and tendon are a major burden on the American healthcare system with limited treatment options. Free Flap reconstructions of lower extremity wounds have an increased failure rate in comparison to elective free flap procedures.These procedures are long… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Dehydrated Human Amnion/Chorion Membrane and Flap-Based Reconstructive Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wound includes exposed critical structures (tendon and/or bone)
- Patient is candidate flap reconstruction
- Patient is candidate for limb salvage
Who cannot join
- Wound involves weight-bearing surfaces (e.g. heel or forefoot wounds),
- Exposed implanted hardware (e.g. surgical plates)
- Anticipated need for future surgical procedures through the same wound
- Wounds resulting from surgical removal of malignancy
- Patients who are not flap candidates (e.g. severe peripheral vascular disease)
- Patients who are not limb salvage candidates (e.g. insensate or ischemic limbs).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Louisiana State University Health Sciences Center - N.O.
New Orleans, Louisiana, 70115
Frank Lau, MD, 504-412-1240, flau@lsuhsc.edu
About this study
Extremity wounds with exposed critical structures, including bone and tendon are a major burden on the American healthcare system with limited treatment options. Free Flap reconstructions of lower extremity wounds have an increased failure rate in comparison to elective free flap procedures.These procedures are long and are associated with a high cost of care, prolonged hospital stays, and are limited by the need for surgical specialist availability and patient vessels suitable for anastomoses. This study will use a new treatment modality which is a commercially ready human amniotic membrane allograft (EpiFix) to promote a granulation tissue wound base that will be suitable for skin grafting, thus forgoing the need for a flap-based for reconstruction. The study goals are to reduce the overall cost of providing definitive treatment by decreasing operative time, length of hospital stay, decrease the need for intensive nursing care and rehabilitation. This study will aim to provide a treatment option that is readily accessible to all patients with these complex wounds in any healthcare setting across the country.
Read the detailed description
53 patients ages 18 and over , presenting with wounds with exposed critical structures (bone and/or tendon) will be enrolled in the study and randomized into one of two groups. 21 patients will be in the standard treatment group (Flap based reconstruction) and 32 patients will be in the dHACM (EpiFix) + skin grafting treatment group (Experimental). Exclusion criteria includes exposed implanted hardware (surgical plates), anticipated need for future surgical procedures through the same wound, wounds resulting from surgical removal of malignancy, and patients who are not free flap candidates.
Data will be collected upon enrollment including:
Background and demographic information Wound size and severity Pain level Medication use Photographs of wound
Flap Reconstruction group (Standard of Care):
Patients in this group will have any dead, damaged or infected tissue removed from the wound and a negative pressure wound dressing will be applied until the wound is clean and adequate for flap reconstruction. Following flap reconstruction, patients typically require a 36-48 hour intensive care unit admission for flap monitoring and 5 days to bed rest to allow for proper healing. If the flap is successful, a dangle protocol will occur until patient increases the dependent position. Once the dangle protocol is completed, patients may require inpatient physical/occupational therapy prior to discharge from the hospital. If patient is not healing the physician may discuss other treatment options including crossing over to the EpiFix arm or amputation.
EpiFix and Skin Graft group:
Patients in this group will have any dead, damaged or infected tissue removed from wound. Once it is free from infection, a thin tissue (EpiFix) will be applied directly to the open wound. This will be covered by sterile wound dressing. After approximately 5-7 days the wound will be assessed for suitability of split thickness skin grafting. If adequately healed, skin grafting will be performed. After 5 days, the graft will be evaluated and if successful, the patient will be discharged home or to a rehab facility. If the wounds are not adequate for skin grafting, additional damaged tissue will removed and EpiFix will be placed until the wound is suitable for grafting. If you do not heal sufficiently the physician will discuss other treatment options including cross over to the standard of care Free Flap or amputation.
Study staff will evaluate the wound twice a week for the first 2 weeks, then once a week until 6 weeks. At this point, the patient will be followed every 4 weeks up to 22 weeks. Visits to the clinic will include wound measurements, photos, pain scale and evaluation of any infection.
- Conditions
- Wounds, Trauma, Injury, Limb Salvage, Soft Tissue Injuries
- Being tested
- Dehydrated Human Amnion/Chorion Membrane, Flap-Based Reconstructive Surgery
- Medical subject headings
- Wounds and Injuries, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydrated Human Amnion/Chorion MembraneDevice
Also called human amniotic membrane allograft, EpiFix
Flap-Based Reconstructive SurgeryProcedure or surgery
Standard of Care surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| Human Amnion/Chorion Membrane + skin graft | Experimental | Dehydrated Human Amnion/Chorion Membrane (dHACM) will be placed on wound at the initial debridement to promote granulation tissue at the wound bed. Approximately 5-7 days following debridement, wound will be assessed for suitability of split thickness skin grafting. If an adequate granulation tissue is present, skin grafting will be performed and assessed for take in 5 days. Receives: Device: Dehydrated Human Amnion/Chorion Membrane |
| Flap Reconstruction (Standard of Care) | Active comparator | A negative pressure wound dressing (NPWD) will be applied at the time of debridement until the wound is clean and adequate for flap reconstruction. Flap-based reconstruction is performed. Following flap reconstruction,patient will have 5 days of bed rest to allow proper healing and coverage of the wounds. If flaps are successful, patients starts a limb dangle protocol which gradually increases the dependent position and allows the flap to acclimate to new physiologic demands. Following dangle protocol patient will require inpatient physical and occupational therapy prior to discharge. Receives: Procedure: Flap-Based Reconstructive Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
"Failure" will be defined as a composite of amputation, persistent exposed critical structures, development of osteomyelitis or need for additional flaps within 6 weeks of treatment.
- Osteomyelitis will be diagnosed as pus from bone requiring long-term (>4 weeks) of IV antibiotics.),
- Experimental Group: "Persistent exposed critical structures" in the experimental arm refers to persistence of exposed nerve, blood vessels, bone or tendon after 4 weeks of dHACM treatment
- Standard of care group: Persistence of exposed nerve, blood vessels, bone or tendon after flap treatment
Measured: Within 6 weeks of treatment
Secondary outcomes (14)
Wound Issue
Were any of the following recorded: wound dehiscence, partial flap loss, or partial skin graft loss requiring prolonged local wound care or other wound treatment (e.g. hyperbaric oxygen therapy, negative pressure wound dressing, other wound devices)?
Measured: within 6 months of initial wound closure
Epidermolysis
Was there any diagnosis of epidermolysis during study
Measured: within 6 months of initial wound closure
Length of ICU stay
Total number of ICU inpatient days
Measured: within 6 months of initial wound closure
Length of inpatient hospital stay
Total number of inpatient hospital days
Measured: within 6 months of initial wound closure
Total treatment time from initial treatment to initial closure (excludes treatment of complications)
Total number of days from initial treatment to end of study
Measured: within 6 months of initial wound closure
Total treatment time from initial treatment to completion of limb salvage (includes treatment of complications)
Total number of days from initial treatment to completion of limb salvage
Measured: within 6 months of initial wound closure
Number of dHACM treatments required
Total number of EpiFix applications
Measured: within 6 months of initial wound closure
Death from any cause
Death from any cause
Measured: within 6 months of initial wound closure
Deep vein thrombosis diagnosed by radiologic imaging (e.g. ultrasound or CT)
Any diagnosis of DVT during study
Measured: within 6 months of initial wound closure
Pulmonary embolus
Any diagnosis of PE during study
Measured: within 6 months of initial wound closure
Ventilator-associated pneumonia
Any diagnosis of vent-associated pneumonia
Measured: within 6 months of initial wound closure
Number of microsurgical revisions needed (arterial or venous)
Number of microsurgical revisions needed
Measured: within 6 months of initial wound closure
Bony non union, bony melanin
Any diagnosis of bony non-union or bony melanin during study
Measured: within 6 months of initial wound closure
Tendon rupture
Any diagnosis of tendon rupture during study
Measured: within 6 months of initial wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study startFeb 2016
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for WoundsStudies of the same condition, open and under way.
- 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
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Lau, MD, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Frank Lau, MD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521258
- Sponsor's protocol ID
- 9167
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kroll SS, Evans GR, Goldberg D, Wang BG, Reece GP, Miller MJ, Robb GL, Baldwin BJ, Schusterman MA. A comparison of resource costs for head and neck reconstruction with free and pectoralis major flaps. Plast Reconstr Surg. 1997 Apr;99(5):1282-6. doi: 10.1097/00006534-199704001-00011.
PubMed 9105354Hong S. Reconstructive surgery: lower extremity coverage. In: Plastic Surgery.Vol 4. 3rd ed. Elsevier Inc.; 2013:127-150.
Colohan S, Saint-Cyr M. Management of lower extremity trauma. In: Plastic Surgery.Vol 4. 3rd ed. Elsevier Inc.; 2013:63-91.
Chung KC, Saddawi-Konefka D, Haase SC, Kaul G. A cost-utility analysis of amputation versus salvage for Gustilo type IIIB and IIIC open tibial fractures. Plast Reconstr Surg. 2009 Dec;124(6):1965-1973. doi: 10.1097/PRS.0b013e3181bcf156.
PubMed 19952652MacKenzie EJ, Jones AS, Bosse MJ, Castillo RC, Pollak AN, Webb LX, Swiontkowski MF, Kellam JF, Smith DG, Sanders RW, Jones AL, Starr AJ, McAndrew MP, Patterson BM, Burgess AR. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. J Bone Joint Surg Am. 2007 Aug;89(8):1685-92. doi: 10.2106/JBJS.F.01350.
PubMed 17671005Gore DC. Outcome and cost analysis for outpatient skin grafting. J Trauma. 1997 Oct;43(4):597-600; discussion 600-2. doi: 10.1097/00005373-199710000-00006.
PubMed 9356054Capla JM, Ceradini DJ, Tepper OM, Callaghan MJ, Bhatt KA, Galiano RD, Levine JP, Gurtner GC. Skin graft vascularization involves precisely regulated regression and replacement of endothelial cells through both angiogenesis and vasculogenesis. Plast Reconstr Surg. 2006 Mar;117(3):836-44. doi: 10.1097/01.prs.0000201459.91559.7f.
PubMed 16525274DeFranzo AJ, Argenta LC, Marks MW, Molnar JA, David LR, Webb LX, Ward WG, Teasdall RG. The use of vacuum-assisted closure therapy for the treatment of lower-extremity wounds with exposed bone. Plast Reconstr Surg. 2001 Oct;108(5):1184-91. doi: 10.1097/00006534-200110000-00013.
PubMed 11604617Hovius SER, Kan HJ, Smit X, Selles RW, Cardoso E, Khouri RK. Extensive percutaneous aponeurotomy and lipografting: a new treatment for Dupuytren disease. Plast Reconstr Surg. 2011 Jul;128(1):221-228. doi: 10.1097/PRS.0b013e31821741ba.
PubMed 21701337Godina M. Early microsurgical reconstruction of complex trauma of the extremities. Plast Reconstr Surg. 1986 Sep;78(3):285-92. doi: 10.1097/00006534-198609000-00001.
PubMed 3737751Parrett BM, Matros E, Pribaz JJ, Orgill DP. Lower extremity trauma: trends in the management of soft-tissue reconstruction of open tibia-fibula fractures. Plast Reconstr Surg. 2006 Apr;117(4):1315-22; discussion 1323-4. doi: 10.1097/01.prs.0000204959.18136.36.
PubMed 16582806Khouri RK, Cooley BC, Kunselman AR, Landis JR, Yeramian P, Ingram D, Natarajan N, Benes CO, Wallemark C. A prospective study of microvascular free-flap surgery and outcome. Plast Reconstr Surg. 1998 Sep;102(3):711-21. doi: 10.1097/00006534-199809030-00015.
PubMed 9727436Stern M. THE GRAFTING OF PRESERVED AMNIOTIC MEMBRANE TO BURNED AND ULCERATED SURFACES, SUBSTITUING SKIN GRAFTS. JAMA. 1913;60(13):973-974.
Gruss JS, Jirsch DW. Human amniotic membrane: a versatile wound dressing. Can Med Assoc J. 1978 May 20;118(10):1237-46.
PubMed 647542Zelen CM, Gould L, Serena TE, Carter MJ, Keller J, Li WW. A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Int Wound J. 2015 Dec;12(6):724-32. doi: 10.1111/iwj.12395. Epub 2014 Nov 26.
PubMed 25424146
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limb Salvage Through Tissue Engineering: A Novel Treatment Modality Using Dehydrated Human Amnion/Chorion Membrane
- ClinicalTrials.gov ID
- NCT03521258
- Acronym / sponsor ID
- 9167
- Conditions
- Wounds, Trauma, Injury, Limb Salvage, Soft Tissue Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 11 May 2018 (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.
Extremity wounds with exposed critical structures, including bone and tendon are a major burden on the American healthcare system with limited treatment options. Free Flap reconstructions of lower extremity wounds have an increased failure rate in comparison to elective free flap procedures.These procedures are long and are associated with a high cost of care, prolonged hospital stays, and are limited by the need for surgical specialist availability and patient vessels suitable for anastomoses. This study will use a new treatment modality which is a commercially ready human amniotic membrane allograft (EpiFix) to promote a granulation tissue wound base that will be suitable for skin grafting, thus forgoing the need for a flap-based for reconstruction. The study goals are to reduce the overall cost of providing definitive treatment by decreasing operative time, length of hospital stay, decrease the need for intensive nursing care and rehabilitation. This study will aim to provide a treatment option that is readily accessible to all patients with these complex wounds in any healthcare setting across the country.
Detailed description
53 patients ages 18 and over , presenting with wounds with exposed critical structures (bone and/or tendon) will be enrolled in the study and randomized into one of two groups. 21 patients will be in the standard treatment group (Flap based reconstruction) and 32 patients will be in the dHACM (EpiFix) + skin grafting treatment group (Experimental). Exclusion criteria includes exposed implanted hardware (surgical plates), anticipated need for future surgical procedures through the same wound, wounds resulting from surgical removal of malignancy, and patients who are not free flap candidates.
Data will be collected upon enrollment including:
Background and demographic information Wound size and severity Pain level Medication use Photographs of wound
Flap Reconstruction group (Standard of Care):
Patients in this group will have any dead, damaged or infected tissue removed from the wound and a negative pressure wound dressing will be applied until the wound is clean and adequate for flap reconstruction. Following flap reconstruction, patients typically require a 36-48 hour intensive care unit admission for flap monitoring and 5 days to bed rest to allow for proper healing. If the flap is successful, a dangle protocol will occur until patient increases the dependent position. Once the dangle protocol is completed, patients may require inpatient physical/occupational therapy prior to discharge from the hospital. If patient is not healing the physician may discuss other treatment options including crossing over to the EpiFix arm or amputation.
EpiFix and Skin Graft group:
Patients in this group will have any dead, damaged or infected tissue removed from wound. Once it is free from infection, a thin tissue (EpiFix) will be applied directly to the open wound. This will be covered by sterile wound dressing. After approximately 5-7 days the wound will be assessed for suitability of split thickness skin grafting. If adequately healed, skin grafting will be performed. After 5 days, the graft will be evaluated and if successful, the patient will be discharged home or to a rehab facility. If the wounds are not adequate for skin grafting, additional damaged tissue will removed and EpiFix will be placed until the wound is suitable for grafting. If you do not heal sufficiently the physician will discuss other treatment options including cross over to the standard of care Free Flap or amputation.
Study staff will evaluate the wound twice a week for the first 2 weeks, then once a week until 6 weeks. At this point, the patient will be followed every 4 weeks up to 22 weeks. Visits to the clinic will include wound measurements, photos, pain scale and evaluation of any infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Amnion/Chorion Membrane + skin graft | Experimental | Device: Dehydrated Human Amnion/Chorion MembraneDehydrated Human Amnion/Chorion Membrane (dHACM) will be placed on wound at the initial debridement to promote granulation tissue at the wound bed. Approximately 5-7 days following debridement, wound will be assessed for suitability of split thickness skin grafting. If an adequate granulation tissue is present, skin grafting will be performed and assessed for take in 5 days. |
| Flap Reconstruction (Standard of Care) | Active comparator | Procedure: Flap-Based Reconstructive SurgeryA negative pressure wound dressing (NPWD) will be applied at the time of debridement until the wound is clean and adequate for flap reconstruction. Flap-based reconstruction is performed. Following flap reconstruction,patient will have 5 days of bed rest to allow proper healing and coverage of the wounds. If flaps are successful, patients starts a limb dangle protocol which gradually increases the dependent position and allows the flap to acclimate to new physiologic demands. Following dangle protocol patient will require inpatient physical and occupational therapy prior to discharge. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Wound includes exposed critical structures (tendon and/or bone)
- Patient is candidate flap reconstruction
- Patient is candidate for limb salvage
Key exclusion criteria (6 listed)
- Wound involves weight-bearing surfaces (e.g. heel or forefoot wounds),
- Exposed implanted hardware (e.g. surgical plates)
- Anticipated need for future surgical procedures through the same wound
- Wounds resulting from surgical removal of malignancy
- Patients who are not flap candidates (e.g. severe peripheral 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 |
|---|---|---|
| Dehydrated Human Amnion/Chorion MembraneAlso: human amniotic membrane allograft, EpiFix | Device | Human Amnion/Chorion Membrane + skin graft |
| Flap-Based Reconstructive SurgeryStandard of Care surgical intervention | Procedure or surgery | Flap Reconstruction (Standard of Care) |
Primary outcome
Treatment failure
Time frame: Within 6 weeks of treatment
"Failure" will be defined as a composite of amputation, persistent exposed critical structures, development of osteomyelitis or need for additional flaps within 6 weeks of treatment. * Osteomyelitis will be diagnosed as pus from bone requiring long-term (>4 weeks) of IV antibiotics.), * Experimental Group: "Persistent exposed critical structures" in the experimental arm refers to persistence of exposed nerve, blood vessels, bone or tendon after 4 weeks of dHACM treatment * Standard of care group: Persistence of exposed nerve, blood vessels, bone or tendon after flap treatment
14 secondary outcomes
Wound Issue
Time frame: within 6 months of initial wound closure
Epidermolysis
Time frame: within 6 months of initial wound closure
Length of ICU stay
Time frame: within 6 months of initial wound closure
Length of inpatient hospital stay
Time frame: within 6 months of initial wound closure
Total treatment time from initial treatment to initial closure (excludes treatment of complications)
Time frame: within 6 months of initial wound closure
Total treatment time from initial treatment to completion of limb salvage (includes treatment of complications)
Time frame: within 6 months of initial wound closure
Number of dHACM treatments required
Time frame: within 6 months of initial wound closure
Death from any cause
Time frame: within 6 months of initial wound closure
Deep vein thrombosis diagnosed by radiologic imaging (e.g. ultrasound or CT)
Time frame: within 6 months of initial wound closure
Pulmonary embolus
Time frame: within 6 months of initial wound closure
Ventilator-associated pneumonia
Time frame: within 6 months of initial wound closure
Number of microsurgical revisions needed (arterial or venous)
Time frame: within 6 months of initial wound closure
Bony non union, bony melanin
Time frame: within 6 months of initial wound closure
Tendon rupture
Time frame: within 6 months of initial wound closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 9105354Kroll SS, Evans GR, Goldberg D, Wang BG, Reece GP, Miller MJ, Robb GL, Baldwin BJ, Schusterman MA. A comparison of resource costs for head and neck reconstruction with free and pectoralis major flaps. Plast Reconstr Surg. 1997 Apr;99(5):1282-6. doi: 10.1097/00006534-199704001-00011.
- BackgroundHong S. Reconstructive surgery: lower extremity coverage. In: Plastic Surgery.Vol 4. 3rd ed. Elsevier Inc.; 2013:127-150.
- BackgroundColohan S, Saint-Cyr M. Management of lower extremity trauma. In: Plastic Surgery.Vol 4. 3rd ed. Elsevier Inc.; 2013:63-91.
- Background: PubMed 19952652Chung KC, Saddawi-Konefka D, Haase SC, Kaul G. A cost-utility analysis of amputation versus salvage for Gustilo type IIIB and IIIC open tibial fractures. Plast Reconstr Surg. 2009 Dec;124(6):1965-1973. doi: 10.1097/PRS.0b013e3181bcf156.
- Background: PubMed 17671005MacKenzie EJ, Jones AS, Bosse MJ, Castillo RC, Pollak AN, Webb LX, Swiontkowski MF, Kellam JF, Smith DG, Sanders RW, Jones AL, Starr AJ, McAndrew MP, Patterson BM, Burgess AR. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. J Bone Joint Surg Am. 2007 Aug;89(8):1685-92. doi: 10.2106/JBJS.F.01350.
- Background: PubMed 9356054Gore DC. Outcome and cost analysis for outpatient skin grafting. J Trauma. 1997 Oct;43(4):597-600; discussion 600-2. doi: 10.1097/00005373-199710000-00006.
- Background: PubMed 16525274Capla JM, Ceradini DJ, Tepper OM, Callaghan MJ, Bhatt KA, Galiano RD, Levine JP, Gurtner GC. Skin graft vascularization involves precisely regulated regression and replacement of endothelial cells through both angiogenesis and vasculogenesis. Plast Reconstr Surg. 2006 Mar;117(3):836-44. doi: 10.1097/01.prs.0000201459.91559.7f.
- Background: PubMed 11604617DeFranzo AJ, Argenta LC, Marks MW, Molnar JA, David LR, Webb LX, Ward WG, Teasdall RG. The use of vacuum-assisted closure therapy for the treatment of lower-extremity wounds with exposed bone. Plast Reconstr Surg. 2001 Oct;108(5):1184-91. doi: 10.1097/00006534-200110000-00013.
- Background: PubMed 21701337Hovius SER, Kan HJ, Smit X, Selles RW, Cardoso E, Khouri RK. Extensive percutaneous aponeurotomy and lipografting: a new treatment for Dupuytren disease. Plast Reconstr Surg. 2011 Jul;128(1):221-228. doi: 10.1097/PRS.0b013e31821741ba.
- Background: PubMed 3737751Godina M. Early microsurgical reconstruction of complex trauma of the extremities. Plast Reconstr Surg. 1986 Sep;78(3):285-92. doi: 10.1097/00006534-198609000-00001.
- Background: PubMed 16582806Parrett BM, Matros E, Pribaz JJ, Orgill DP. Lower extremity trauma: trends in the management of soft-tissue reconstruction of open tibia-fibula fractures. Plast Reconstr Surg. 2006 Apr;117(4):1315-22; discussion 1323-4. doi: 10.1097/01.prs.0000204959.18136.36.
- Background: PubMed 9727436Khouri RK, Cooley BC, Kunselman AR, Landis JR, Yeramian P, Ingram D, Natarajan N, Benes CO, Wallemark C. A prospective study of microvascular free-flap surgery and outcome. Plast Reconstr Surg. 1998 Sep;102(3):711-21. doi: 10.1097/00006534-199809030-00015.
- Individual participant dataSharing planned: No
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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.
Frank Lau, MD principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dehydrated Human Amnion/Chorion Membrane and Flap-Based Reconstructive Surgery in people with Wounds and Trauma, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
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 3 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 11 May 2018. 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 United States. 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 Frank Lau, MD (504-412-1240, flau@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: Within 6 weeks of treatment). 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 NCT03521258, which also lists 21 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 11 May 2018.