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

Not Applicable

Completed

• Conditions: Soft Tissue Injuries
• Interventions: Procedure: Negative Pressure Wound Therapy; Procedure: Conventional treatment

• Registration Number: NCT04569305
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Study First Posted: 2020-09-29
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. All patients aged 18 years or above with foot and ankle trauma resulting in soft tissue injury with bones and tendon exposed
2. Patients consenting to participate in the study

Exclusion Criteria

1. Patients with uncontrolled diabetes mellitus
2. Patients with multiple fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy	Negative Pressure Wound Therapy	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.
Conventional treatment	Conventional treatment	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.

Primary Outcome Measures

Name	Time	Method
size of wound covered with healthy granulation tissue	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.

Trial Locations

Locations (1)

Roqayyah Munawwer Khursheed; 🇵🇰 Karachi, Sindh, Pakistan