Impact of Wound Infection on Pain and Wound Healing Clinical Trial
Official title:
Impact of Preoperative Local Water-Filtered Infrared-A (wIRA) Irradiation on Postoperative Wound Healing - A Randomized Patient- and Observer Blinded Controlled Clinical Trial
The purpose of this study is to dermine whether local-water filtered infrared-A (wIRA) irradiation can reduce postoperative wound infection. wIRA irradiation is applied 20min directly preoperatively, before patients underwent abdominal surgery. The wIRA is a harmless light source, that has been described before. We test the impact and clinical outcome of patients undergoing a one-time preoperative wIRA irradiation on postoperative wound healing.
Wound healing is a complex pathophysiological process that is related to pain, discomfort
and immobility of patients and when not well controlled may lead to devastating and
morbidity related wound infections. Furthermore, prolonged hospital stay, increased pain and
consecutive increased drug consumption is often associated with postoperative wound
infections. Although the average costs of wound infections are difficult to assess, there is
no doubt that a prophylactic tool in controlling postoperative wound healing would have
tremendous potential. Recent studies indicate that the application of different forms of
thermal energy to the skin surface decreases postoperative wound infections significantly.
It is known that high-normal arterial oxygen tension levels have decreased surgical wound
infection from 11% to 5%. The application of water-filtered infrared A (wIRA) irradiation
has been successfully applied in patients with ulcus cruris and superficial skin-tumors to
alleviate pain and regulation of the body temperature in neonatology. The simple
preoperative whole body warming for 30 min before surgery resulted in a statistically
reduced occurrence of postoperative wound infections. A more recent study showed the
beneficial effects of postoperative wIRA application on wound healing. The effects of wIRA
leading to this success in therapy can be explained by thermal and non-thermal effects. A
major advantage of the wIRA vs. the application of simple warming blankets lies upon the
effective penetration of the wIRA applied energy within the deep subcutaneous tissue at
depths of 2-3 cm. Further effects of the applied energy lead to vasodilation of capillaries
with consecutive effective conduction of energetic blood flow into deeper tissue layers.
Non-thermal effects of the wIRA application consist of direct stimulation and active
immunomodulation by specialized immune cells. Furthermore, wIRA can induce protective
proteins, e.g. ferritin in the skin and potentially influences common cross-talks within
cells and extracellular matrices. These effects display regulatory roles in wound repair
processes that may also be responsible for positive cosmetic results. More important for the
clinical assessment of wound healing in the early phase of hospitalization is the effect of
wIRA to significantly reduce postoperative pain. Surgery and postoperative pain evoke stress
related effects that are induced by profound neuroendocrine changes in cytokine activity and
related processes. Increased blood flow, due to vasodilation, helps to strongly eliminate
accumulated pain mediators, lactic acid and potential bacterial toxins. The metabolism is
induced and mediates also non-thermal effects such as attraction of immune cells and
potential effects on nociceptors. These direct effects of wIRA can be easily followed when
postoperative irradiation is performed. The problem of developing wound infections may rely
within the first hours after and already during the operation, when the wound gets
"preconditioned" with potential mediators or bacteria that may lead to postoperative
encountered wound infections. A recent study indicated that immediate postoperative warming
for 2 hours after hernia surgery may provide comparable benefits to seven days of warming.
According to the idea of preventing deleterious preconditions in the process of wound
healing, we tested here, the one time preoperative application of wIRA and its impact on
postoperative wound healing and related clinical questions. Comparable to preoperative
antibiotic single shot treatment we relied on the expansive impact of preoperative wIRA
application.
The prospective randomized controlled clinical trial is designed to study the effects of
single time preoperative wIRA irradiation on the postoperative outcome of wound infections
after visceral surgery.
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care