Impact of Preoperative Local Water-Filtered Infrared-A (wIRA) Irradiation on Postoperative Wound Healing (Hydrosun)
Primary Purpose
Wound Infection Rate After Surgery, Impact of Wound Infection on Pain and Wound Healing
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
wIRA irradiation
visible light only
Sponsored by
About this trial
This is an interventional supportive care trial for Wound Infection Rate After Surgery focused on measuring wound infection, surgery, surgical wound infection rate, wound healing
Eligibility 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
Sites / Locations
- Klinikum rechts der Isar der Technischen Universität
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
wIRA irradiation
visible light only
Arm Description
Patients in Group A received local water-filtered infrared A (wIRA) irradiation once for 20 min preoperatively.
Patients assigned to Group B only received normal visible light application for 20 min prior to surgery.
Outcomes
Primary Outcome Measures
Postoperative wound infection rate
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
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
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).
Full Information
NCT ID
NCT01654679
First Posted
July 22, 2012
Last Updated
September 5, 2012
Sponsor
German Research Foundation
Collaborators
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01654679
Brief Title
Impact of Preoperative Local Water-Filtered Infrared-A (wIRA) Irradiation on Postoperative Wound Healing
Acronym
Hydrosun
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Research Foundation
Collaborators
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection Rate After Surgery, Impact of Wound Infection on Pain and Wound Healing
Keywords
wound infection, surgery, surgical wound infection rate, wound healing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
wIRA irradiation
Arm Type
Active Comparator
Arm Description
Patients in Group A received local water-filtered infrared A (wIRA) irradiation once for 20 min preoperatively.
Arm Title
visible light only
Arm Type
Sham Comparator
Arm Description
Patients assigned to Group B only received normal visible light application for 20 min prior to surgery.
Intervention Type
Device
Intervention Name(s)
wIRA irradiation
Other Intervention Name(s)
wIRA (Hydrosun® radiator; Hydrosun Medizinaltechnik, Müllheim, Germany)
Intervention Description
wIRA irradiation for 20min prior to surgery. The distance between the light bulb and the skin surface was 27cm.
Intervention Type
Other
Intervention Name(s)
visible light only
Other Intervention Name(s)
Standard light bulb with visible normal conventional light.
Intervention Description
visible light application at a distance of 27cm from the skin surface with for 20 min.
Primary Outcome Measure Information:
Title
Postoperative wound infection rate
Description
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
Time Frame
day 2 to 8 and day 30
Secondary Outcome Measure Information:
Title
Wound pain postoperative
Description
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.
Time Frame
day 2 to 8 and after 30 days
Title
Wound healing postoperative
Description
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).
Time Frame
day 2 to 8 and after 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beat M Künzli, MD
Organizational Affiliation
Klinikum rechts der Isar, Technische Universität München, Munich, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum rechts der Isar der Technischen Universität
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16845694
Citation
Hartel M, Hoffmann G, Wente MN, Martignoni ME, Buchler MW, Friess H. Randomized clinical trial of the influence of local water-filtered infrared A irradiation on wound healing after abdominal surgery. Br J Surg. 2006 Aug;93(8):952-60. doi: 10.1002/bjs.5429.
Results Reference
background
PubMed Identifier
24169161
Citation
Kunzli BM, Liebl F, Nuhn P, Schuster T, Friess H, Hartel M. Impact of preoperative local water-filtered infrared A irradiation on postoperative wound healing: a randomized patient- and observer-blinded controlled clinical trial. Ann Surg. 2013 Dec;258(6):887-94. doi: 10.1097/SLA.0000000000000235.
Results Reference
derived
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Impact of Preoperative Local Water-Filtered Infrared-A (wIRA) Irradiation on Postoperative Wound Healing
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