Effect of Negative Pressure Wound Therapy for Soft Tissue Injuries of Foot and Ankle in Patients at a Tertiary Care Hospital

Study Overview
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Brief Summary
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Effect of Negative Pressure Wound Therapy for Soft Tissue Iinjuries of Foot and Ankle in Patients at a Tertiary care Hospital. To evaluate the effect of negative pressure wound therapy for soft tissue injuries of foot and ankle.This will be assessed through measuring the wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up.

Detailed Description
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All patients aged 18 years or above with foot and ankle trauma resulting in soft tissue injury with or without bones and tendon exposed were included in the study. 35 patients were randomized into Negative Pressure Wound Therapy group and 35 in conventional treatment group.In NPWT group ,NPWT was applied to injured area of foot and ankle after debridement and cleaning of the necrosed/dead tissue. The effect of technique was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up at 10 days ,20 days and 27 days respectively. In Conventional treatment group patients were kept on simple moist gauze dressings and the wound was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimeter square on followup at 10 days , 20 days and 27 days respectively.

Official Title
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Principal Investigator

Conditions
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Soft Tissue Injuries

Intervention / Treatment
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* Procedure: Negative Pressure Wound Therapy
* Procedure: Conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients aged 18 years or above with foot and ankle trauma resulting in soft tissue injury with bones and tendon exposed Patients consenting to participate in the study Exclusion Criteria: Patients with uncontrolled diabetes mellitus Patients with multiple fractures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative Pressure Wound Therapy<br>Negative Pressure Wound Therapy was applied to injured area of foot and ankle after debridement and cleaning of the necrosed/dead tissue. The effect of technique was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up. | Procedure: Negative Pressure Wound Therapy<br>* NPWT technique was applied to injured area of the foot and ankle after debridement and cleaning of the necrosed tissue and using Vacuum Assisted Closure (VAC) consisting of evacuation tube, vacuum pump, collecting canister and a multiporous polyurethane sponge. VAC dressings were changed every 72 hours.<br>|
| Active Comparator: Conventional treatment<br>Simple moist gauze dressing applied to injured area of foot and ankle after debridement and cleaning of the necrosed/dead tissue. The effect of treatment was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up. | Procedure: Conventional treatment<br>* In conventional treatment moist gauze dressings were applied and change of dressings were done daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size of wound covered with healthy granulation tissue | The effect of technique was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up. | 27 days |