Clinical trial NCT05653297: Negative Pressure Wound Therapy in Traumatic Skin Loss
Official title: A Randomized Study of The Use of Negative Pressure Wound Therapy in Traumatic Skin & Soft Tissue Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Traumatic Skin Loss
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post Traumatic Patients with skin \& soft tissue loss with no contraindication to use of VAC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Granulation tissue formation
timeFrame: 2 weeks
measure: Graft Take
timeFrame: 4 days after coverage
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.