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

NCT ID: NCT04569305

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-06-30

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.

Conditions

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Soft Tissue Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
This study will be single blinded means that patient will be unaware of his/her treatment method.

Study Groups

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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.

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type PROCEDURE

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

Interventions

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Negative Pressure Wound Therapy

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.

Intervention Type PROCEDURE

Conventional treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Roqayyah Munawwer Khursheed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roqayyah M Khursheed, MBBS

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

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Roqayyah Munawwer Khursheed

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 19426531 (View on PubMed)

Related Links

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http://www.josr-online.com/content/4/1/14

Negative pressure wound therapy for soft tissue injuries around the foot and ankle

Other Identifiers

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1408

Identifier Type: -

Identifier Source: org_study_id

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