Addition of Negative Pressure Wound Therapy to Standard Gauze Dressings for Acute Wounds in a Limited-Resource Setting

Wounds and Injuries Clinical Trial

Official title:

Randomized Trial Comparing the Negative Pressure Wound Therapy to Standard Gauze Dressings for Acute Wounds in Mbingo Baptist Hospital, Cameroon

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02479542
• Other study ID #: SU 34186
• Status: Withdrawn
• Phase: N/A
• First received: June 21, 2015
• Last updated: April 24, 2017
• Start date: June 2015
• Est. completion date: July 1, 2015

Study information

• Verified date: November 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

B. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2015
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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

1. a minimum of 25 sq cm in cross dimension with a minimum wound depth of 1 cm at the deepest point or

2. 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

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Other:
• Standard Gauze Dressing
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.

Device:
• WiCare NPWT dressing
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

References & Publications (15)

Armstrong 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. — View Citation

Bagheri 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. Review. — View Citation

Borgquist O, Gustafsson L, Ingemansson R, Malmsjö 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. — View Citation

Campbell 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. — View Citation

Chariker 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):1510-20. doi: 10.1097/PRS.0b013e3181a20563. — View Citation

Dorafshar 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. — View Citation

Dunn 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. — View Citation

Jeffery SL. Advanced wound therapies in the management of severe military lower limb trauma: a new perspective. Eplasty. 2009 Jul 21;9:e28. — View Citation

Lee 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. — View Citation

Malmsjö 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. — View Citation

Malmsjö 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. — View Citation

Morykwas 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. — View Citation

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. Review. — View Citation

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. — View Citation

Wilkes 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5-19 days following application of dressing
Secondary	Rate of Wound Contraction	The rate of wound contraction with NPWT for those wounds that do not reach definitive wound closure by study endpoint.	5-19 days following application of dressing