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

September 5, 2012 updated by: Mark Hartel, German Research Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universitat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Standard light bulb with visible normal conventional light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative wound infection rate
Time Frame: day 2 to 8 and day 30

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
day 2 to 8 and day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound pain postoperative
Time Frame: day 2 to 8 and after 30 days
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.
day 2 to 8 and after 30 days
Wound healing postoperative
Time Frame: day 2 to 8 and after 30 days

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).
day 2 to 8 and after 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Research Foundation

Collaborators

Technical University of Munich

Investigators

  • Study Director: Beat M Künzli, MD, Klinikum rechts der Isar, Technische Universität München, Munich, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 22, 2012

First Submitted That Met QC Criteria

July 28, 2012

First Posted (Estimate)

August 1, 2012

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HydrosunWoundHealing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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