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Completed

NCT Number: NCT04569305

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

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.

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Key information

Conditions

Soft Tissue Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roqayyah Munawwer Khursheed

Karachi, Sindh, 75850, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative Pressure Wound therapy

Procedure

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.

Conventional treatment

Procedure

In conventional treatment moist gauze dressings were applied and change of dressings were done daily.

Primary outcomes

  1. size of wound covered with healthy granulation tissue

    Time frame: 27 days

    The effect of technique was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Principal Investigator

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2020
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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