Negative Pressure Wound Therapy in Traumatic Skin Loss

NCT05653297 | Unknown FDA Device

• 1 other identifier: NPWT In Traumatic Wounds
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post Traumatic Skin Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Length of hospital stay

  1 month

Study Arms (2)

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

Interventions

Vacuum-Assisted Closure DEVICE

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

Group B (Experimental Group)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 21200280 BACKGROUND

• 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.

  PMID: 30390545 BACKGROUND

• 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.

  PMID: 21712971 BACKGROUND

• 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.

  PMID: 31034574 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31528055 BACKGROUND

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Central Study Contacts

David Ph Ryad, Resident

CONTACT

01064388822; dr.davidphilip1996@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 16, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 16, 2022

Record last verified: 2022-12