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Wound Infection Rate After SurgeryHydrosunNCT01654679

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

A study testing wIRA irradiation and visible light only in people with Wound Infection Rate After Surgery and Impact of Wound Infection on Pain and Wound Healing, run by German Research Foundation at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
wIRA irradiation and visible light only
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
1 siteGermany
Study dates
Aug 2008to Jul 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Klinikum rechts der Isar der Technischen Universität

    Munich, Bavaria, 81675

Other trials in Germany

About this study

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.

Read the 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.

Being tested
wIRA irradiation, visible light only
Keywords
wound infection, surgery, surgical wound infection rate, wound healing
Medical subject headings
Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • wIRA irradiationDevice

    Also called wIRA (Hydrosun® radiator; Hydrosun Medizinaltechnik, Müllheim, Germany)

    wIRA irradiation for 20min prior to surgery. The distance between the light bulb and the skin surface was 27cm.

  • visible light onlyOther

    Also called Standard light bulb with visible normal conventional light.

    visible light application at a distance of 27cm from the skin surface with for 20 min.

Study groups in NCT01654679
Study groupRoleWhat they receive
wIRA irradiationActive comparatorPatients in Group A received local water-filtered infrared A (wIRA) irradiation once for 20 min preoperatively.
Receives: Device: wIRA irradiation
visible light onlySham comparatorPatients assigned to Group B only received normal visible light application for 20 min prior to surgery.
Receives: Other: visible light only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: day 2 to 8 and day 30

Secondary outcomes (2)
  1. 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.

    Measured: day 2 to 8 and after 30 days

  2. 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).

    Measured: day 2 to 8 and after 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2012 (estimated)
  2. Study startAug 2008
  3. Primary completionJun 2010
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01654679
Sponsor's protocol ID
HydrosunWoundHealing
Acronym
Hydrosun
Status last verified
Sep 2012
First submitted
22 Jul 2012
Last updated
6 Sep 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16845694
  • 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.

    PubMed 24169161

Questions about this trial

What is this clinical trial studying?

A study testing wIRA irradiation and visible light only in people with Wound Infection Rate After Surgery and Impact of Wound Infection on Pain and Wound Healing, run by German Research Foundation at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative wound infection rate (time frame: day 2 to 8 and day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01654679, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.

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