Effectiveness of hyperbaric oxygen therapy as an adjuvant to conventional therapy in the salvage of compromised flaps: Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Flap Surface Area: Each discolored surface area of flap will be measured by using manual planimetry before starting the treatment
研究概览
简要总结
Flap surgery remains a cornerstone of reconstructive procedures using skin grafts and flaps are essential for
restoring tissue integrity following trauma, chronic disease, surgical excision, or burns. However, despite
optimal planning and surgical technique, flap or graft failure may still occur due to factors such as ischemia,
venous congestion, or poor wound bed quality. These complications can result in delayed healing, additional
surgical interventions, increased healthcare costs, and psychosocial distress for patients.
.
Current treatment strategies for compromised grafts and flaps include local wound care, vacuum assisted
closure, surgical debridement, and additional reconstructive procedures. These are associated with increases
in healthcare- associated costs, patient discomfort, and may lead to additional donor site morbidity. Flap
surgeries widely used in reconstructive procedure to restore ischemic reperfusion resulting from trauma,
surgical excision or burns.
Hyperbaric oxygen therapy is an adjunctive treatment modality that deliver 100% oxygen at elevated
atmosphere pressure (1-2 ATA). It significantly increased dissolve oxygen in plasma due to elevated arterial
partial pressure of oxygen. Hyperbaric oxygen therapy provides administration of hyper oxygenation that
supports key process in wound healing, fibroblast proliferation, collagen synthesis, bacterial clearance by
generation of oxygen free radical. Its therapeutic benefits in restoring compromised flaps as it improves flap
viability & necrosis when surgical re-exploration reveals no correctable cause.
.
HBOT may help in saving tissues that are compromised and not healing properly. It promotes salvage of
compromised flaps or grafts and uncomplicated healing after ablative or reconstructive surgery. It has also
been used to improve ischemic wounds before skin grafting and to support ischemic flaps.
This thesis aim to assess the efficacy of HBOT in improving outcomes of compromised flaps. There are
studies for HBOT on effectiveness in restoring compromised flap but their is lack of direct study which
comparing HBOT as an adjuvant to conventional therapy in compromised flap in term of effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •American Society of Anesthesiology physical status 1 and 2 Patients with Compromised Flaps.
排除标准
- •Any disorders of active upper respiratory tract infection, any active lung pathology
- •Pregnant or breastfeeding females
- •Claustrophobic patients
- •Patients with diabetes or immunosuppressive diseases 5.CSOM or tympanic membrane perforation
- •Emphysema with CO2 retention
- •History suggestive of optic neuritis
- •History of spontaneous pneumothorax
- •History of thorax surgery
- •Seizure disorders
- •Uncontrolled high fever
- •Viral infections.
结局指标
主要结局
1.Flap Surface Area: Each discolored surface area of flap will be measured by using manual planimetry before starting the treatment
时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy
& after each session of HBOT
时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy
2.Temperature by thermometer
时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy
3.Turgor by palpation/skin pinch
时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy
4. Random Blood Sugar (RBS) by glucometre
时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy
5. Colour on prick by sterile needle
时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy
次要结局
- Find healing time, hospital stay & complication rates in comparison to conventional flap(care in the management of compromised flaps)
研究者
Mohd Ali
Uttar Pradesh University Of Medical Sciences
