Negative Pressure Wound Therapy in Traumatic Skin Loss

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Study of The Use of Negative Pressure Wound Therapy in Traumatic Skin & Soft Tissue Loss

Conditions
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Post Traumatic Skin Loss

Intervention / Treatment
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* Device: Vacuum-Assisted Closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No age preference. No gender preference. Acute traumatic wounds. Admitted to the hospital. Exclusion Criteria: Exposed Vessels, Nerves & Organs. Active bleeding. Ischemic limb. Opening into body cavity. Vulnerable body organs. Necrotic tissue with eschar present.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A (Control Group)<br>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)<br>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. | Device: Vacuum-Assisted Closure<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Granulation tissue formation | Healthy granulation tissue appears pink to red due to new capillary formation, soft to touch, moist appears bumpy, and typically painless. | 2 weeks | 
| Graft Take | The graft take assessment by clinical examination | 4 days after coverage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Duration of hospital stay since time of trauma till discharge from hospital after coverage of the wound. | 1 month |