Wounds and InjuriesNCT02479542
Addition of Negative Pressure Wound Therapy to Standard Gauze Dressings for Acute Wounds in a Limited-Resource Setting
A study testing Standard Gauze Dressing and WiCare NPWT dressing in people with Wounds and Injuries, run by Stanford University.
Trial summary
The worldwide prevalence of open wounds is estimated to be approximately 200 million per year. Negative Pressure Wound Therapy (NPWT), the application of a controlled vacuum to an open wound cavity, has been clinically demonstrated in developed nations to speed the healing time of open wounds by a factor of two or… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Standard Gauze Dressing and WiCare NPWT dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to 1 Jul 2015
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be at least 15 years of age,
- Acute wounds <21 days from any soft tissue traumatic, surgical, or infectious cause.
- Wound size must be either
- a minimum of 25 sq cm in cross dimension with a minimum wound depth of 1 cm at the deepest point or
- a minimum of 16 sq cm in cross dimension with a minimum depth of 1.5 cm at deepest point.
- Wounds must have been cleaned and debrided of all debris, foreign body contamination (dirt, grass, bone fragments, other debris), necrotic tissue, and pus
Show all 9Show fewer
- Wound should be considered stable (not evoloving) and ready for dressing changes every 72hours.
- Necrotizing soft tissue infection wounds will only be considered after control of infection through medical and surgical treatment and the wound stable enough for a dressing change every 72 hours.
- Aamputation stump wounds can be included if all other criteria fulfilled.
Who cannot join
- A wound that would be able to be closed primarily or within 5 days through suture closure, flap rotation or immediate skin graft coverage.
- A wound greater than or equal to 21 cm in either length or width at the initial measurement.
- A wound in the perineum: defined by the pubic bone anteriorly and the anus posteriorly.
- A wound with a visible blood vessel of >3mm.
- The presence of known cancer in the wound.
- Acute burns or burns with skin grafts wound.
- Latex allergy.
- Expected mortality within 30 days of admission from co-exisitng medical or surgical condition.
About this study
Official title: Randomized Trial Comparing the Negative Pressure Wound Therapy to Standard Gauze Dressings for Acute Wounds in Mbingo Baptist Hospital, Cameroon
The worldwide prevalence of open wounds is estimated to be approximately 200 million per year. Negative Pressure Wound Therapy (NPWT), the application of a controlled vacuum to an open wound cavity, has been clinically demonstrated in developed nations to speed the healing time of open wounds by a factor of two or more, and to aid in complete recovery with less scar tissue. Use of NPWT devices has not been feasible in an limited-resource settings due to cost, bulk, and requirement for consistent electricity. This study aims to follow up prior clinical studies that have established the safety and efficacy of simplified NPWT, by assessing changes in wound closure time and wound contraction rate when simplified NPWT is used in a limited-resource setting.
Read the detailed description
Hypothesis:
Application of WiCare Wound Pump to a standard gauze dressing will result in faster time to definitive wound closure and rate of healing in acute wounds from trauma, infection, or surgery as compared to standard gauze dressing without negative pressure.
Study Design A. Single center prospective trial to be conducted at Mbingo Baptist Hospital (MBH) a multispecialty hospital located in North-West Cameroon that provides complex surgical care.
- Phase II C. Two arm trial with all patients with eligible wounds offered entrance into Phase II trial D. Blinding: Non E. Indication and patient population: Acute wounds secondary to trauma, infection, or surgical excision in adult patients (>15 year old) F. Sample size: 100 total; based on Schoenfeld's Method to compare two-sample Log-Rank Test with Power of 80%, significance level=5% G. Random Permuted Blocks: Patients will be randomized in blocks of 4 using the following schema Treatment A) WiCare, Treatment B) Standard Dressing: AABB, ABAB, BAAB, BABA, BBAA, and ABBA.
- Conditions
- Wounds and Injuries
- Being tested
- Standard Gauze Dressing, WiCare NPWT dressing
- Keywords
- Negative-Pressure Wound Therapy, Wound Healing, Global Health, Cameroon
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Gauze DressingOther
Following consenting of participant, the wound will be photographed with the Wound Zoom imaging system and measured for greatest length, width, and depth. For patients randomized to the control arm, only standard gauze dressings will be applied and changed daily. Wounds with the standard gauze dressings will be photo-documented and measured with the same variables every 72 hours. Wounds and dressing will be evaluated daily for drainage, exudate, presence of infection, and gauze dressings will be changed daily.
WiCare NPWT dressingDevice
Following consenting of participant, the wound will be photographed with the Wound Zoom imaging system and measured for greatest length, width, and depth. For patients randomized to the simplified NPWT arm, the standard gauze dressing will be placed then the the WiCare NPWT dressing will be applied. Wounds and WiCare NPWT device will be evaluated daily for drainage, exudate, presence of infection, drainage in pump, integrity of air tight seal. Wounds will be changed by protocol with photo documentation every 72 hours for a total of 18 days or achievement of primary endpoint.
| Study group | Role | What they receive |
|---|---|---|
| Standard Gauze Dressing | Active comparator | Patients with wounds that meet eligibility criteria will be randomized, if randomized to the Standard Gauze Dressing Arm, a saline moistened sterile gauze will be packed into the wound with dry gauze and either tape or other means will be used to secure the dressing. The dressing will be changed daily and measured and photodocumented every 72 hours with the Wound Zoom system. Receives: Other: Standard Gauze Dressing |
| WiCare NPWT dressing | Experimental | Patients with wounds that meet eligibility criteria will be randomized, if randomized to the WiCare NPWT Dressing Arm, a saline moistened sterile gauze will be packed into the wound and then the WiCare dressing and wound pump will be placed on the wound. The dressing will be changed, measured and photodocumented every 72 hours with the Wound Zoom system. Receives: Device: WiCare NPWT dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Wound Closure
The effect of simplified negative pressure wound therapy device use on the time to definitive wound closure or time to wound becoming appropriate for discharge for eschar formation.
Measured: 5-19 days following application of dressing
Secondary outcomes (1)
Rate of Wound Contraction
The rate of wound contraction with NPWT for those wounds that do not reach definitive wound closure by study endpoint.
Measured: 5-19 days following application of dressing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion1 Jun 2015
- Study completion1 Jul 2015
Why it stopped: Regulatory issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Stanford 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry M. Wren MD, Stanford University
- Investigators
- Sherry M Wren, MD, Principal investigator, Stanford UniversityBrannon Weeks, BA, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479542
- Sponsor's protocol ID
- SU 34186
- Status last verified
- Nov 2015
- First submitted
- 21 Jun 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Saxena V, Hwang CW, Huang S, Eichbaum Q, Ingber D, Orgill DP. Vacuum-assisted closure: microdeformations of wounds and cell proliferation. Plast Reconstr Surg. 2004 Oct;114(5):1086-96; discussion 1097-8. doi: 10.1097/01.prs.0000135330.51408.97.
PubMed 15457017Borgquist O, Gustafsson L, Ingemansson R, Malmsjo M. Micro- and macromechanical effects on the wound bed of negative pressure wound therapy using gauze and foam. Ann Plast Surg. 2010 Jun;64(6):789-93. doi: 10.1097/SAP.0b013e3181ba578a.
PubMed 20489409Chariker ME, Gerstle TL, Morrison CS. An algorithmic approach to the use of gauze-based negative-pressure wound therapy as a bridge to closure in pediatric extremity trauma. Plast Reconstr Surg. 2009 May;123(5):1510-1520. doi: 10.1097/PRS.0b013e3181a20563.
PubMed 19407624Orgill 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 21200280Wilkes R, Zhao Y, Kieswetter K, Haridas B. Effects of dressing type on 3D tissue microdeformations during negative pressure wound therapy: a computational study. J Biomech Eng. 2009 Mar;131(3):031012. doi: 10.1115/1.2947358.
PubMed 19154071Malmsjo M, Ingemansson R, Martin R, Huddleston E. Negative-pressure wound therapy using gauze or open-cell polyurethane foam: similar early effects on pressure transduction and tissue contraction in an experimental porcine wound model. Wound Repair Regen. 2009 Mar-Apr;17(2):200-5. doi: 10.1111/j.1524-475X.2009.00461.x.
PubMed 19320888Malmsjo M, Ingemansson R, Martin R, Huddleston E. Wound edge microvascular blood flow: effects of negative pressure wound therapy using gauze or polyurethane foam. Ann Plast Surg. 2009 Dec;63(6):676-81. doi: 10.1097/SAP.0b013e31819ae01b.
PubMed 19887926Dorafshar AH, Franczyk M, Gottlieb LJ, Wroblewski KE, Lohman RF. A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device. Ann Plast Surg. 2012 Jul;69(1):79-84. doi: 10.1097/SAP.0b013e318221286c.
PubMed 21712704Dunn R, Hurd T, Chadwick P, Cote J, Cockwill J, Mole T, Smith J. Factors associated with positive outcomes in 131 patients treated with gauze-based negative pressure wound therapy. Int J Surg. 2011;9(3):258-62. doi: 10.1016/j.ijsu.2010.12.005. Epub 2010 Dec 25.
PubMed 21187174Campbell PE, Smith GS, Smith JM. Retrospective clinical evaluation of gauze-based negative pressure wound therapy. Int Wound J. 2008 Jun;5(2):280-6. doi: 10.1111/j.1742-481X.2008.00485.x.
PubMed 18494633Jeffery SL. Advanced wound therapies in the management of severe military lower limb trauma: a new perspective. Eplasty. 2009 Jul 21;9:e28.
PubMed 19696875Lee HJ, Kim JW, Oh CW, Min WK, Shon OJ, Oh JK, Park BC, Ihn JC. Negative pressure wound therapy for soft tissue injuries around the foot and ankle. J Orthop Surg Res. 2009 May 9;4:14. doi: 10.1186/1749-799X-4-14.
PubMed 19426531Bagheri Nejad S, Allegranzi B, Syed SB, Ellis B, Pittet D. Health-care-associated infection in Africa: a systematic review. Bull World Health Organ. 2011 Oct 1;89(10):757-65. doi: 10.2471/BLT.11.088179. Epub 2011 Jul 20.
PubMed 22084514Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.
PubMed 16291063Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.
PubMed 9188970
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing the Negative Pressure Wound Therapy to Standard Gauze Dressings for Acute Wounds in Mbingo Baptist Hospital, Cameroon
- ClinicalTrials.gov ID
- NCT02479542
- Acronym / sponsor ID
- SU 34186
- Conditions
- Wounds and Injuries
- Keywords
- Negative-Pressure Wound Therapy, Wound Healing, Global Health, Cameroon
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Regulatory issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 24 Jun 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.
The worldwide prevalence of open wounds is estimated to be approximately 200 million per year. Negative Pressure Wound Therapy (NPWT), the application of a controlled vacuum to an open wound cavity, has been clinically demonstrated in developed nations to speed the healing time of open wounds by a factor of two or more, and to aid in complete recovery with less scar tissue. Use of NPWT devices has not been feasible in an limited-resource settings due to cost, bulk, and requirement for consistent electricity. This study aims to follow up prior clinical studies that have established the safety and efficacy of simplified NPWT, by assessing changes in wound closure time and wound contraction rate when simplified NPWT is used in a limited-resource setting.
Detailed description
Hypothesis:
Application of WiCare Wound Pump to a standard gauze dressing will result in faster time to definitive wound closure and rate of healing in acute wounds from trauma, infection, or surgery as compared to standard gauze dressing without negative pressure.
Study Design A. Single center prospective trial to be conducted at Mbingo Baptist Hospital (MBH) a multispecialty hospital located in North-West Cameroon that provides complex surgical care.
- Phase II C. Two arm trial with all patients with eligible wounds offered entrance into Phase II trial D. Blinding: Non E. Indication and patient population: Acute wounds secondary to trauma, infection, or surgical excision in adult patients (>15 year old) F. Sample size: 100 total; based on Schoenfeld's Method to compare two-sample Log-Rank Test with Power of 80%, significance level=5% G. Random Permuted Blocks: Patients will be randomized in blocks of 4 using the following schema Treatment A) WiCare, Treatment B) Standard Dressing: AABB, ABAB, BAAB, BABA, BBAA, and ABBA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Gauze Dressing | Active comparator | Other: Standard Gauze DressingPatients with wounds that meet eligibility criteria will be randomized, if randomized to the Standard Gauze Dressing Arm, a saline moistened sterile gauze will be packed into the wound with dry gauze and either tape or other means will be used to secure the dressing. The dressing will be changed daily and measured and photodocumented every 72 hours with the Wound Zoom system. |
| WiCare NPWT dressing | Experimental | Device: WiCare NPWT dressingPatients with wounds that meet eligibility criteria will be randomized, if randomized to the WiCare NPWT Dressing Arm, a saline moistened sterile gauze will be packed into the wound and then the WiCare dressing and wound pump will be placed on the wound. The dressing will be changed, measured and photodocumented every 72 hours with the Wound Zoom system. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be at least 15 years of age,
- Acute wounds <21 days from any soft tissue traumatic, surgical, or infectious cause.
- Wound size must be either
- Wounds must have been cleaned and debrided of all debris, foreign body contamination (dirt, grass, bone fragments, other debris), necrotic tissue, and pus
- Wound should be considered stable (not evoloving) and ready for dressing changes every 72hours.
Key exclusion criteria (8 listed)
- A wound that would be able to be closed primarily or within 5 days through suture closure, flap rotation or immediate skin graft coverage.
- A wound greater than or equal to 21 cm in either length or width at the initial measurement.
- A wound in the perineum: defined by the pubic bone anteriorly and the anus posteriorly.
- A wound with a visible blood vessel of >3mm.
- The presence of known cancer in the wound.
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 |
|---|---|---|
| Standard Gauze DressingFollowing consenting of participant, the wound will be photographed with the Wound Zoom imaging system and measured for greatest length, width, and depth. For patients randomized to the control arm, only standard gauze dressings will be applied and changed daily. Wounds with the standard gauze dressings will be photo-documented and measured with the same variables every 72 hours. Wounds and dressing will be evaluated daily for drainage, exudate, presence of infection, and gauze dressings will be changed daily. | Other | Standard Gauze Dressing |
| WiCare NPWT dressingFollowing consenting of participant, the wound will be photographed with the Wound Zoom imaging system and measured for greatest length, width, and depth. For patients randomized to the simplified NPWT arm, the standard gauze dressing will be placed then the the WiCare NPWT dressing will be applied. Wounds and WiCare NPWT device will be evaluated daily for drainage, exudate, presence of infection, drainage in pump, integrity of air tight seal. Wounds will be changed by protocol with photo documentation every 72 hours for a total of 18 days or achievement of primary endpoint. | Device | WiCare NPWT dressing |
Primary outcome
Time to Wound Closure
Time frame: 5-19 days following application of dressing
The effect of simplified negative pressure wound therapy device use on the time to definitive wound closure or time to wound becoming appropriate for discharge for eschar formation.
1 secondary outcome
Rate of Wound Contraction
Time frame: 5-19 days following application of dressing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 15457017Saxena V, Hwang CW, Huang S, Eichbaum Q, Ingber D, Orgill DP. Vacuum-assisted closure: microdeformations of wounds and cell proliferation. Plast Reconstr Surg. 2004 Oct;114(5):1086-96; discussion 1097-8. doi: 10.1097/01.prs.0000135330.51408.97.
- Background: PubMed 20489409Borgquist O, Gustafsson L, Ingemansson R, Malmsjo M. Micro- and macromechanical effects on the wound bed of negative pressure wound therapy using gauze and foam. Ann Plast Surg. 2010 Jun;64(6):789-93. doi: 10.1097/SAP.0b013e3181ba578a.
- Background: PubMed 19407624Chariker ME, Gerstle TL, Morrison CS. An algorithmic approach to the use of gauze-based negative-pressure wound therapy as a bridge to closure in pediatric extremity trauma. Plast Reconstr Surg. 2009 May;123(5):1510-1520. doi: 10.1097/PRS.0b013e3181a20563.
- 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 19154071Wilkes R, Zhao Y, Kieswetter K, Haridas B. Effects of dressing type on 3D tissue microdeformations during negative pressure wound therapy: a computational study. J Biomech Eng. 2009 Mar;131(3):031012. doi: 10.1115/1.2947358.
- Background: PubMed 19320888Malmsjo M, Ingemansson R, Martin R, Huddleston E. Negative-pressure wound therapy using gauze or open-cell polyurethane foam: similar early effects on pressure transduction and tissue contraction in an experimental porcine wound model. Wound Repair Regen. 2009 Mar-Apr;17(2):200-5. doi: 10.1111/j.1524-475X.2009.00461.x.
- Background: PubMed 19887926Malmsjo M, Ingemansson R, Martin R, Huddleston E. Wound edge microvascular blood flow: effects of negative pressure wound therapy using gauze or polyurethane foam. Ann Plast Surg. 2009 Dec;63(6):676-81. doi: 10.1097/SAP.0b013e31819ae01b.
- Background: PubMed 21712704Dorafshar AH, Franczyk M, Gottlieb LJ, Wroblewski KE, Lohman RF. A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device. Ann Plast Surg. 2012 Jul;69(1):79-84. doi: 10.1097/SAP.0b013e318221286c.
- Background: PubMed 21187174Dunn R, Hurd T, Chadwick P, Cote J, Cockwill J, Mole T, Smith J. Factors associated with positive outcomes in 131 patients treated with gauze-based negative pressure wound therapy. Int J Surg. 2011;9(3):258-62. doi: 10.1016/j.ijsu.2010.12.005. Epub 2010 Dec 25.
- Background: PubMed 18494633Campbell PE, Smith GS, Smith JM. Retrospective clinical evaluation of gauze-based negative pressure wound therapy. Int Wound J. 2008 Jun;5(2):280-6. doi: 10.1111/j.1742-481X.2008.00485.x.
- Background: PubMed 19696875Jeffery SL. Advanced wound therapies in the management of severe military lower limb trauma: a new perspective. Eplasty. 2009 Jul 21;9:e28.
- Background: PubMed 19426531Lee HJ, Kim JW, Oh CW, Min WK, Shon OJ, Oh JK, Park BC, Ihn JC. Negative pressure wound therapy for soft tissue injuries around the foot and ankle. J Orthop Surg Res. 2009 May 9;4:14. doi: 10.1186/1749-799X-4-14.
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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.
Sherry M Wren, MD principal investigator
Stanford University
Brannon Weeks, BA principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Standard Gauze Dressing and WiCare NPWT dressing in people with Wounds and Injuries, run by Stanford 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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 26 Apr 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to Wound Closure (time frame: 5-19 days following application of dressing). 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 NCT02479542, which also lists 15 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 26 Apr 2017.