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

Soft Tissue Injuries Clinical Trial

Official title:

Principal Investigator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04569305
• Other study ID #: 1408
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Soft Tissue Injuries

Intervention

Procedure:
• 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.
• Conventional treatment
In conventional treatment moist gauze dressings were applied and change of dressings were done daily.

Locations

Country	Name	City	State
Pakistan	Roqayyah Munawwer Khursheed	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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