Impact of Preoperative Local Water-Filtered Infrared-A (wIRA) Irradiation on Postoperative Wound Healing (Hydrosun)

This study has been completed.
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Mark Hartel, German Research Foundation
ClinicalTrials.gov Identifier:
NCT01654679
First received: July 22, 2012
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Wound Infection Rate After Surgery
Impact of Wound Infection on Pain and Wound Healing
Device: wIRA irradiation
Other: visible light only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by German Research Foundation:

Primary Outcome Measures:
  • Postoperative wound infection rate [ Time Frame: day 2 to 8 and day 30 ] [ Designated as safety issue: No ]

    The rate of wound infection was assessed from day 2 to 8 and day 30 post surgery.

    The wound infection rate was assessed by a visual analogue scale (VAS) Group A: irradiated with local water-filtered infrared A (wIRA) irradiation Group B: irriadiate with conventional visible light



Secondary Outcome Measures:
  • Wound pain postoperative [ Time Frame: day 2 to 8 and after 30 days ] [ Designated as safety issue: No ]
    Wound pain was assessed at day 2 to 8 (on a daily basis) and after day 30 post surgery, comparing patients from Group A (wIRA) and group B (only conventional light) application.

  • Wound healing postoperative [ Time Frame: day 2 to 8 and after 30 days ] [ Designated as safety issue: No ]

    Wound healing was assessed at day 2 - 8 (daily) and after 30 days with a visual analogue scale (VAS).

    The wound healing was assessed while comparing the results from group A (wIRA) and group B (conventional light).



Enrollment: 400
Study Start Date: August 2008
Study Completion Date: July 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: wIRA irradiation
Patients in Group A received local water-filtered infrared A (wIRA) irradiation once for 20 min preoperatively.
Device: wIRA irradiation
wIRA irradiation for 20min prior to surgery. The distance between the light bulb and the skin surface was 27cm.
Other Name: wIRA (Hydrosun® radiator; Hydrosun Medizinaltechnik, Müllheim, Germany)
Sham Comparator: visible light only
Patients assigned to Group B only received normal visible light application for 20 min prior to surgery.
Other: visible light only
visible light application at a distance of 27cm from the skin surface with for 20 min.
Other Name: Standard light bulb with visible normal conventional light.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing aseptic surgery with a median or transverse laparotomy
  • informed consent
  • Patients age between 30 and 80 years

Exclusion Criteria:

  • pregnancy
  • laparoscopic surgery
  • operation time more than 6 hours
  • signs of infection (local or systemic)
  • MRSA positive patients
  • myocardial infarction within 6 wks prior to surgery
  • radio- or chemotherapy within 4 wks prior to surgery
  • body temperature above 38°C for the last 5 days prior to surgery
  • cachexia
  • leucocytopenia
  • liver cirrhosis Child B or C
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01654679

Locations
Germany
Klinikum rechts der Isar der Technischen Universität
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
German Research Foundation
Technische Universität München
Investigators
Study Director: Beat M Künzli, MD Klinikum rechts der Isar, Technische Universität München, Munich, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Hartel, Priv.-Doz. Dr. med., German Research Foundation
ClinicalTrials.gov Identifier: NCT01654679     History of Changes
Other Study ID Numbers: HydrosunWoundHealing
Study First Received: July 22, 2012
Last Updated: September 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Research Foundation:
wound infection
surgery
surgical wound infection rate
wound healing

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014