Negative Pressure Wound Therapy in Traumatic Skin Loss

A Randomized Study of The Use of Negative Pressure Wound Therapy in Traumatic Skin & Soft Tissue Loss

Assessment of the effectiveness of negative pressure wound therapy on post-traumatic wounds, as regard to :

• The period of granulation tissue formation.
• The infection rate in NPWT in comparison to conventional dressing.
• The rate of graft take after NPWT.
• The length of hospital stay.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Traumatic Skin Loss
• Intervention / Treatment: Device: Vacuum-Assisted Closure

Detailed Description

Over the last 15 years, negative-pressure wound therapy "NPWT" has become commonly used for treatment of a wide variety of complex wounds. Many clinicians have noted a dramatic response when negative-pressure wound therapy technology has been used, prompting a number of scientific investigations related to its mechanism of action and clinical trials determining its efficacy.

NPWT is a modality that has shown great promise and delivered significantly better results in the clinical care of acute as well as chronic wounds. It is designed to seal the wound site using foam dressing linked to an electronic pump, which applies a pressure ranging from -75 to -150 mmHg. As a matter of fact, NPWT's impact on wound healing appears to be the consequence of multiple effects, each contributing to the overall positive influence on wound healing. Current research indicates that there are four primary NPWT mechanisms of action: Macrodeformation, Microdeformation, Fluid removal and Environmental control of the wound.

Even if the role of NPWT in promoting wound healing has been largely accepted, there is a lack of evidence (few high-level clinical studies) regarding its effectiveness and further research is needed to better understand the mechanisms of action.

Traumatic wounds vary from abrasions and minor skin incisions or tears to wounds with extensive tissue damage or loss and damage to bone and internal organs. Delayed wound healing particularly in difficult wounds is a major concern, It leads to pain, morbidity, prolonged treatment, and require major reconstructive surgery which imposes enormous social and financial burden.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: David Ph Ryad, Resident; Phone Number: 01064388822; Email: dr.davidphilip1996@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post Traumatic Patients with skin & soft tissue loss with no contraindication to use of VAC

Description

Inclusion Criteria:

• No age preference.
• No gender preference.
• Acute traumatic wounds.
• Admitted to the hospital.

Exclusion Criteria:

• Exposed Vessels, Nerves & Organs.
• Active bleeding.
• Ischemic limb.
• Opening into body cavity.
• Vulnerable body organs.
• Necrotic tissue with eschar present.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A (Control Group); will undergo conventional dressing daily until the wound is ready for reconstruction, Then coverage of the wound with conventional tie over for 4 days.
Group B (Experimental Group); NPWT (MEDWAY GROUP VAC) will be applied on a continuous mode between -75 & -150 mm Hg for 4 days per session for indefinite number of sessions until the wound is ready for reconstruction, Then it will be applied after coverage of the wound for 1 session.	Device: Vacuum-Assisted Closure; NPWT (MEDWAY GROUP VAC) will be applied on post traumatic raw areas until the wound is ready for reconstruction, Then it will be applied over skin graft after coverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Granulation tissue formation	Healthy granulation tissue appears pink to red due to new capillary formation, soft to touch, moist appears "bumpy," and typically painless.	2 weeks
Graft Take	The graft take assessment by clinical examination	4 days after coverage

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Duration of hospital stay since time of trauma till discharge from hospital after coverage of the wound.	1 month

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Orgill DP, Bayer LR. Update on negative-pressure wound therapy. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:105S-115S. doi: 10.1097/PRS.0b013e318200a427.
• Bellot GL, Dong X, Lahiri A, Sebastin SJ, Batinic-Haberle I, Pervaiz S, Puhaindran ME. MnSOD is implicated in accelerated wound healing upon Negative Pressure Wound Therapy (NPWT): A case in point for MnSOD mimetics as adjuvants for wound management. Redox Biol. 2019 Jan;20:307-320. doi: 10.1016/j.redox.2018.10.014. Epub 2018 Oct 23.
• Peinemann F, Sauerland S. Negative-pressure wound therapy: systematic review of randomized controlled trials. Dtsch Arztebl Int. 2011 Jun;108(22):381-9. doi: 10.3238/arztebl.2011.0381. Epub 2011 Jun 3.
• Pappalardo V, Frattini F, Ardita V, Rausei S. Negative Pressure Therapy (NPWT) for Management of Surgical Wounds: Effects on Wound Healing and Analysis of Devices Evolution. Surg Technol Int. 2019 May 15;34:56-67.
• El-den S, Reizian A, Yahia A, Zedan A, Shormana M. Effect of Negative Pressure Wound Therapy on Post-traumatic Wound Healing. International Journal of Novel Research in Healthcare and Nursing. 2021;7(3):590-608.
• Agarwal P, Kukrele R, Sharma D. Vacuum assisted closure (VAC)/negative pressure wound therapy (NPWT) for difficult wounds: A review. J Clin Orthop Trauma. 2019 Sep-Oct;10(5):845-848. doi: 10.1016/j.jcot.2019.06.015. Epub 2019 Jun 20.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: November 27, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NPWT In Traumatic Wounds

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes