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引用本文:简喜超, 简扬, 邓呈亮. 2025版《中国糖尿病足防治实践指南》解读[J]. 中华医学美学美容杂志, 2026, 32(2): 99-103. DOI: 10.3760/cma.j.cn114657-20251215-00266.
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Athina Stamati1 · Athanasios Christoforidis2
Received: 7 October 2024 / Accepted: 31 December 2024 / Published online: 10 January 2025 © The Author(s) 2025
Abstract
Aims To assess the efficacy and safety of automated insulin delivery (AID) systems compared to standard care in managing glycaemic control during pregnancy in women with Type 1 Diabetes Mellitus (T1DM).
Methods We searched MEDLINE, Cochrane Library, registries and conference abstracts up to June 2024 for randomized controlled trials (RCTs) and observational studies comparing AID to standard care in pregnant women with T1DM. We con-ducted random effects meta-analyses for % of 24-h time in range of 63–140 mg/dL (TIR), time in hyperglycaemia (>140 mg/ dl and>180 mg/dL), hypoglycaemia (<63 mg/dl and<54 mg/dL), total insulin dose (units/kg/day), glycemic variability (%), changes in HbA1c (%), maternal and fetal outcomes.
Results Thirteen studies (450 participants) were included. AID significantly increased TIR (Mean difference, MD 7.01%, 95% CI 3.72–10.30) and reduced time in hyperglycaemia>140 mg/dL and>180 mg/dL (MD – 5.09%, 95% CI – 9.41 to – 0.78 and MD – 2.44%, 95% CI – 4.69 to – 0.20, respectively). Additionally, glycaemic variability was significantly reduced (MD – 1.66%, 95% CI – 2.73 to – 0.58). Other outcomes did not differ significantly.
Conclusion AID systems effectively improve glycaemic control during pregnancy in women with T1DM by increasing TIR and reducing hyperglycaemia without any observed adverse short-term effects on maternal and fetal outcomes.
Keywords Automated insulin delivery · Pregnancy · Type 1 diabetes mellitus · Systematic review · Meta-analysis
Emily R. Kindal1, Kaitlin J. Larson2, Luis G. Fernandez3,4,5#, Sean F. O’Keefe6, Marc R. Matthews7*
1 Medical Student IV, Royal College of Surgeons in Ireland, Dublin, Ireland
2 Surgical Resident, The Arrowhead Surgical Residency, Glendale, Arizona
3 Department of Surgery, University of Texas Health Science Center, Tyler, USA
4 Trauma Wound Care, UT Health East, Tyler, USA
5 Department of Surgery, University of Texas Medical Branch, Galveston, USA
6 Business Development Manager, Saint Paul, US
7 University of Arizona & Creighton University Schools of Medicine, The Arizona Burn Center, Phoenix, Arizona
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How to cite this paper: Kindal, E.R., Larson, K.J., Fernandez, L.G., O’Keefe, S.F. and Matthews, M.R. (2022) The Use of the V.A.C. RX-4 for Multiple Soft Tissue Wound Application in the Single Patient: A Case Report. Surgical Science, 13, 155-163. https://doi.org/10.4236/ss.2022.133020
Received: January 28, 2022
Accepted: March 26, 2022
Published: March 29, 2022
Copyright © 2022 by author(s) and Scientific Research Publishing Inc. This work is licensed under the Creative Commons Attribution International License (CC BY 4.0). http://creativecommons.org/licenses/by/4.0/
Contact burn injuries account for a considerable proportion of admissions that frequently require debridement. Such debridements of these multiple open wounds might benefit from the application of negative pressure wound therapy (NPWT) for the removal of proinflammatory mediators and to promote granulation tissue with macrostrain and microstrain. Having four or more Vacuum Assist Closure (V.A.C.) Ulta devices connected to the same patient for adequate wound coverage is cumbersome in the management of the patient’s wound care and tethers the patient to the bed. The V.A.C. RX-4 is a multichannel device that can deliver NPWT with a smaller footprint. In addition, the V.A.C. RX-4 has a weight of 16 lbs. versus one V.A.C Ulta which is 7.4 lbs. Therefore, collectively, four V.A.C. Ultas would equal 29.6 lbs. or almost double the weight of a single V.A.C. RX-4. Use of the V.A.C. RX-4 by healthcare providers can mean greater mobility for the patient and easier transport between patient destinations within the hospital. This case report demonstrates the utility of the V.A.C. RX-4 for open and freshly debrided, large soft tissue wounds in a burn patient.
# UT Texas, Assistant Clinical Professor of Surgery/Family Practice UT Health North East, Tyler, Texas, Adjunct Clinical Professor of Medicine and Nursing, University of Texas, Arlington, Texas, Past Commanding General TXSG Medical Brigade, Austin, TX USA, Chairman Emeritus, Division of Trauma Surgery/Surgical Critical Care, Associate Trauma Medical Director and Chief of Trauma Surgical Critical Care Unit, Christus Trinity Mother Frances Health System, Tyler, Texas, Surgical Attending, Adjunct Associate Professor, University of North Texas, Denton, Texas.
Keywords
V.A.C. RX-4, Negative Pressure Wound Therapy, Wounds, V.A.C. Ulta, Footprint, Burns
1. Introduction
Contact burn injuries account for a considerable proportion of admissions to the Arizona Burn Center during the summer months [1] [2]. Reported in 2019, pavement burn injuries sustained in Arizona from May through October make up 61% of their reported contact burn injuries [2]. The largest constituent of these injuries is found in patients > 56 years old who are susceptible to falls and subsequent pavement burns [2].
NPWT (Negative Pressure Wound Therapy) is routinely used in the treatment of acute and chronic wounds after debridement such as seen with these pavement contact burn injuries. V.A.C. (Vacuum Assisted Closure) therapy uses mechanisms of macrostrain and microstrain to promote healing. The negative pressure wound therapy (NPWT) creates a vacuum at the wound surface thereby drawing wound edges together, removing infectious and proinflammatory material, and promoting the formation of granulation tissue [3] [4]. For these reasons, VAC dressings are used in burn patients to quickly promote granulation tissue development and healing prior to split-thickness skin grafting [5] [6]. Although NPWT is an effective option for open wounds, in the past NPWT’s use has been limited to burn injuries affecting a single wound or one body region. In practice this limitation has been partially overcome with the use of a Y-connector to create a diverting channel and thereby allowing NPWT to two body areas via the V.A.C. Ulta (3 M (formerly KCI), St. Paul, MN) device which provides the negative pressure. Furthermore, open wounds can also be connected to one another over normal intervening skin that is not injured in a process called bridging. Bridging utilizes sponge placement between the two open wounds followed by coverage with an overlying acrylic drape followed by the application of negative pressure. Multiple wounds covered in this fashion utilize V.A.C. Ulta devices for the delivery of negative pressure.
Recent advancements in V.A.C. technology have led to the development of the multichannel V.A.C. RX-4 (3M (formerly KCI), St. Paul, MN) device which allows NPWT to be employed across at least four separate body areas that have open wounds. This effectively decreased the footprint of four V.A.C. Ulta devices into one compact unit. This case report demonstrates the utility of the V.A.C. RX-4 in NPWT for multiple open, large soft tissue defects or wounds in a burn patient. The manuscript was found to be exempt by the institutional review board at Valleywise Medical Center (formerly Maricopa Integrated Health Systems) protocol number CR2022-001 according to 45CFR46.104.
2. Case Report
A 72-year-old female presented to the Arizona Burn Center with 14% total body surface (TBSA), full thickness contact burns to the bilateral upper extremities (Figure 1(a) and Figure 1(b)), left flank and torso (Figure 2), and left lower extremities (Figure 3(a) and Figure 3(b)) after falling and then laying on hot asphalt. This patient had multiple comorbidities including congestive heart failure, hypertension, insulin-requiring diabetes mellitus and morbid obesity which prevented her lifting herself off the payment and thereby sustaining her fullthickness burn injuries. On post-admission day seven after medical stabilization followed by medical optimization, the patient underwent initial sharp wound debridement to multiple burn wounds down to the fascia layer. Her wounds were dressed in Mepitel (Molnlycke, Gothenburg, Sweden) followed by Kerlix (Medtronic, Dublin, Ireland) soaked in hypochlorous acid (Urgo Medical North America, Ft. Worth, TX). On day 12 of admission the patient returned to the OR for interval debridement of her multiple open wounds. Four V.A.C. Ulta devices were utilized for delivery of NPWT after placing black foam sponges onto the wounds followed by acrylic drapes. The V.A.C. Ulta device was set to deliver−125 mmHg NPWT. For her third operative wound debridement, rather than placing four individual V.A.C. Ulta devices, a V.A.C. RX-4 device was utilized to the wounds on her bilateral upper extremities (Figure 4 and Figure 5), left flank, torso and left lower extremity (Figure 6). This enabled NPWT to be managed with a single device (Figure 7). Her hospital course was complicated by multiple pneumonias and sepsis requiring intravenous antibiotics as well as respiratory failure requiring prolonged ventilation and a subsequent tracheostomy. Because of the heavy use of aminoglycoside antibiotics to treat her pneumonias and septic episodes, she developed renal failure and subsequently required intermittent hemodialysis (IHD). The patient eventually underwent split-thickness skin grafting to her well-granulated wounds. The patient’s wounds had over 90% graft-take prior to discharge, however, the patient required IHD to maintain clearance of her blood urea nitrogen and creatinine by-products. She was discharged after 61 days to a skilled nursing facility requiring only topical wound care, IHD three times a week, and follow-up in the burn clinic. After two months post-discharge with greater than 95% of her wounds healed, the patient elected to stop her intermittent hemodialysis. She went to hospice for comfort care where she expired two months post-discharge.
3. Discussion
Developed at the behest of the United States Air Force and Department of Defense, a multichannel, NPWT vacuum assisted closure device with a smaller footprint was developed that would meet safe-to-fly requirements [7]. The development and subsequent application of the V.A.C. RX-4 achieved its intended goals for the military. Despite its therapeutic benefits, there are only two articles found in the clinical literature regarding the V.A.C RX-4 [7] [8]. Physical space is a premium in the transport of wounded military personnel with battlefield injuries from a war zone on critical-care air transports [8]. Consequently, multiple V.A.C. Ulta devices, if required for multiple wounds would occupy greater physical space and is collectively heavier to carry. In our laboratory, using photographic imagery and stacking four V.A.C. Ulta devices side-by-side, one can see that the basic footprint of four V.A.C. Ulta devices is exceptionally large (Figure 8). When the taped perimeters of the single V.A.C. RX-4 and four V.A.C. Ulta devices are placed next to each other, the V.A.C. RX-4 has an obvious smaller footprint (9.125 cm × 14.5 cm) than the four V.A.C. Ultas (15.75 cm × 17 cm) (Figure 9). Once physically removed from the perimeter of its blue tape, the blue tape footprint of the four combined V.A.C. Ultas were much larger than the single V.A.C. RX-4 (Figure 10). By placing the V.A.C. RX-4 device inside of the four V.A.C. Ulta blue border footprint, the V.A.C. RX-4’s size is observed to be less than the footprint of the four V.A.C. Ultas (Figure 11).
The V.A.C. RX-4 device is also applicable to civilian burn and trauma center patients where there are multiple wounds on a single patient as seen in this case report [7] [8]. The V.A.C. RX-4’s use allows for easier patient transfer and nursing care, especially when the patient is traveling between the intensive care unit, floor, and the operating room. It is more physically ergonomic for the nursing staff having one V.A.C. RX-4 device to work with instead of having to lift and position four individual V.A.C. Ulta devices. The V.A.C. RX-4 has a weight of 16 lbs. while one VAC Ulta weighs 7.4 lbs. However, collectively, four VAC Ultas would equal 29.6 lbs. or almost double the weight of a single V.A.C. RX-4. Fewer individual devices assist the nurses in providing easier wound care management and help the patient when working with physical therapy or when transferring to a chair or a bedside commode.
4. Conclusion
The V.A.C. RX-4 device with its smaller footprint will provide NPWT to multiple open wounds on the trauma or burn patient without the need for Y-connectors or wound bridging. Future studies should assess if this device is less cumbersome for the nursing or physical therapy staff during patient transport or if fewer independent devices attached to the patient help with the delivery of wound care and ambulation, not tethering the patient to a hospital bed. Nursing staff should find that the management of V.A.C. RX-4 on the medical wards is made easier by only going to one control panel rather than searching multiple devices for any needed NPWT adjustments. Contemporary studies should be conducted in the United States military and civilian burn and trauma centers in order to bolster the clinical literature for this lesser known but useful device.
Acknowledgements
The authors would like to acknowledge the assistance of Lora Whooley, BS, for taking multiple photographs in the benchtop laboratory of Dr. Marc “Dutch” Matthews in this manuscript’s development.
Conflicts of Interest
Dr. Matthews is a surgical consultant and on the speaker’s bureau for 3M/KCI, Urgo North America/SteadMed, Inc; MIMEDX.
Dr. Fernandez is a surgical consultant and on the speaker’s bureau for 3M/KCI, Urgo North America/SteadMed, Inc.
Mr. Sean O’Keefe is an executive representative for 3M.
References
[1] Harrington, W.Z., Strohschein, B.L., Reedy, D., Harrington, J.E. and Schiller, W.R. (1995) Pavement Temperature and Burns: Streets of Fire. Annals of Emergency Medi cine, 26, 563-568. https://doi.org/10.1016/S0196-0644(95)70005-6
[2] Kowal-Vern, A., Matthews, M.R., Richey, K.N., Ruiz, K., Peck, M., Jain, A. and Foster, K.N. (2019) “Streets of Fire” Revisited: Contact Burns. Burns & trauma, 7. https://doi.org/10.1186/s41038-019-0169-9
[3] Banwell, P.E. and Musgrave, M. (2004) Topical Negative Pressure Therapy: Mechanisms and Indications. International Wound Journal: Review, 1, 95-106. https://doi.org/10.1111/j.1742-4801.2004.00031.x
[4] Ibrahim, Z.M., Waked, I.S. and Ibrahim, O. (2019) Negative Pressure Wound Therapy versus Microcurrent Electrical Stimulation in Wound Healing in Burns. Journal of Wound Care, 28, 214-219. https://doi.org/10.12968/jowc.2019.28.4.214
[5] Saaiq, M., Hameed-Ud-Din, K.M. and Chaudhery, S.M. (2010) Vacuum-Assisted Closure Therapy as a Pretreatment for Split Thickness Skin Grafts. Journal of College of Physicians and Surgeons Pakistan, 20, 675-679.
[6] Seswandhana, M.R., Anzhari, S., Dachlan, I., Wirohadidjojo, Y.W. and Aryandono,T. (2020) A Case Series of Negative Pressure Wound Therapy as a Promising Treatment in Patients with Burn Injury. International Journal of Surgery Case Reports, 69, 64-67. https://doi.org/10.1016/j.ijscr.2020.03.034
[7] DeKruff, D. (2016) Multichannel Negative Pressure Wound Therapy Vacuum Assisted Closure. https://apps.dtic.mil/sti/pdfs/AD1021863.pdf
[8] (2019) KCI Introduces Latest Advancement in Negative Pressure Wound Therapy Designed Specifically for Multiple Traumatic Wounds. International Wound Journal, 16, 313-315.
This article is excerpted from the Surgical Science by Wound World.
伤口世界平台生态圈,以“关爱人间所有伤口患者”为愿景,连接、整合和拓展线上和线下的管理慢性伤口的资源,倡导远程、就近和居家管理慢性伤口,解决伤口专家的碎片化时间的价值创造、诊疗经验的裂变复制、和患者的就近、居家和低成本管理慢性伤口的问题。
2019广东省医疗行业协会伤口管理分会年会
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