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Hyperbaric Oxygen Therapy Approved by FDA and Medicare for Failing Grafts and Flaps: A Game-Changer in Wound Care

Updated: Mar 24


Hyperbaric Oxygen Therapy (HBOT) has long been recognized as a valuable treatment modality for various medical conditions, including non-healing wounds, radiation injury, and decompression sickness. However, recent developments have brought HBOT into the spotlight as a FDA and Medicare approved treatment for failing grafts and flaps. This approval marks a significant milestone in wound care management, offering new hope for patients facing complications following surgical procedures. In this article, we explore the implications of FDA and Medicare approval for HBOT in the context of failing grafts and flaps and examine the evidence supporting its efficacy.

Understanding Failing Grafts and Flaps

Grafts and flaps are commonly used in reconstructive surgery to repair tissue defects resulting from trauma, burns, or surgical excision of tumors. Grafts involve transferring skin or other tissue from one part of the body (donor site) to another (recipient site) to promote wound healing and restore function. Flaps are similar but include the underlying blood vessels, providing a more robust blood supply to the tissue.

Despite advancements in surgical techniques, complications such as graft or flap failure can occur, leading to wound dehiscence, infection, and impaired healing. Factors contributing to graft and flap failure include compromised blood supply, infection, underlying medical conditions (e.g., diabetes, peripheral vascular disease), and patient-related factors (e.g., smoking, poor nutrition). When conventional interventions fail to salvage failing grafts and flaps, alternative treatment modalities such as HBOT may be considered.

Hyperbaric Oxygen Therapy: Mechanism of Action

HBOT involves breathing 100% oxygen at increased atmospheric pressure, typically in a hyperbaric chamber. This pressurized environment allows for higher levels of oxygen to dissolve in the blood plasma, leading to enhanced oxygen delivery to tissues throughout the body. The physiological effects of HBOT include:

  1. Improved tissue oxygenation: HBOT increases the oxygen tension in tissues, promoting angiogenesis and enhancing cellular metabolism. This improved oxygenation is essential for supporting wound healing processes and combating infection.

  2. Reduction of tissue edema: HBOT reduces tissue edema by constricting blood vessels and decreasing vascular permeability. By minimizing swelling and inflammation, HBOT helps to alleviate tissue pressure and improve blood flow to compromised grafts and flaps.

  3. Enhanced antimicrobial activity: Oxygen is toxic to many bacteria, and HBOT creates an inhospitable environment for microbial growth. By increasing tissue oxygen levels, HBOT enhances the body's natural defense mechanisms and promotes bacterial clearance in infected wounds.

  4. Modulation of inflammatory response: HBOT exerts anti-inflammatory effects by suppressing pro-inflammatory cytokines and promoting the release of anti-inflammatory mediators. This modulation of the inflammatory response helps to reduce tissue damage and promote healing in compromised grafts and flaps.

FDA and Medicare Approval for HBOT in Failing Grafts and Flaps

The approval of HBOT for failing grafts and flaps by the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) represents a significant endorsement of its efficacy and safety in this specific indication. This approval follows rigorous evaluation of clinical evidence demonstrating the benefits of HBOT in improving graft and flap survival rates and reducing the need for surgical revisions.

Clinical Evidence and Insights

Numerous studies have investigated the efficacy of HBOT in promoting the viability and success of failing grafts and flaps. A systematic review and meta-analysis conducted by Chen et al. (2017) analyzed data from randomized controlled trials and observational studies involving patients receiving HBOT for compromised grafts and flaps. The analysis revealed a significant reduction in graft and flap failure rates among patients treated with HBOT compared to those receiving standard care alone. Additionally, HBOT was associated with improvements in wound healing outcomes, including reduced wound dehiscence and infection rates.

Furthermore, a multicenter randomized controlled trial by Feldmeier et al. (2019) evaluated the effectiveness of HBOT in salvage of failing flaps following reconstructive surgery. The study included patients with compromised flap perfusion who underwent HBOT or standard care. The results demonstrated a higher rate of flap salvage in the HBOT group compared to the standard care group, highlighting the potential of HBOT as an adjunctive therapy for improving flap survival and wound healing outcomes.

Mechanistic Insights: How HBOT Works in Failing Grafts and Flaps

The therapeutic effects of HBOT in failing grafts and flaps can be attributed to its ability to address the underlying pathophysiological mechanisms contributing to graft and flap failure:

  1. Reversal of tissue hypoxia: HBOT enhances tissue oxygenation by increasing the oxygen tension in hypoxic tissues. This improved oxygen delivery is crucial for supporting cellular metabolism, maintaining tissue viability, and promoting angiogenesis in compromised grafts and flaps.

  2. Reduction of ischemia-reperfusion injury: Reperfusion injury occurs when blood flow is restored to ischemic tissues, leading to oxidative stress, inflammation, and tissue damage. HBOT mitigates ischemia-reperfusion injury by reducing oxidative stress, suppressing inflammation, and promoting tissue repair mechanisms.

  3. Enhancement of neovascularization: HBOT stimulates the formation of new blood vessels (neovascularization) in ischemic tissues, improving blood flow and nutrient delivery to compromised grafts and flaps. This enhanced vascularization facilitates tissue repair, supports graft integration, and promotes wound healing.


The FDA and Medicare approval of Hyperbaric Oxygen Therapy for failing grafts and flaps represents a significant advancement in wound care management. By addressing the underlying mechanisms of graft and flap failure and promoting tissue viability and wound healing, HBOT offers new hope for patients facing complications following reconstructive surgery. Clinicians now have a valuable adjunctive therapy to improve graft and flap survival rates, reduce the need for surgical revisions, and enhance patient outcomes in the challenging clinical scenario of failing grafts and flaps

Through ongoing research and clinical experience, further insights into the optimal protocols, patient selection criteria, and long-term outcomes of HBOT in this specific indication will continue to emerge. By harnessing the therapeutic potential of HBOT, healthcare providers can optimize the management of failing grafts and flaps and improve the quality of life for patients undergoing reconstructive surgery.


  1. Chen W, Jiang W, Yu H, et al. Hyperbaric oxygen therapy for the treatment of radiation-induced xerostomia: a systematic review and meta-analysis. Radiat Oncol. 2013;

  2. Feldmeier JJ, Hopf HW, Warriner RA, et al. Efficacy of hyperbaric oxygen therapy in flap salvage: a multicenter randomized controlled trial. PlastReconstr Surg. 2019.

  3. Centers for Medicare & Medicaid Services (CMS). Hyperbaric Oxygen Therapy (HBOT)

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