NCT01654679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

July 22, 2012

Last Update Submit

September 5, 2012

Conditions

Wound Infection Rate After SurgeryImpact of Wound Infection on Pain and Wound Healing

Keywords

wound infectionsurgerysurgical wound infection ratewound healing

Outcome Measures

Primary Outcomes (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

    day 2 to 8 and day 30

Secondary Outcomes (2)

  • Wound pain postoperative

    day 2 to 8 and after 30 days

  • Wound healing postoperative

    day 2 to 8 and after 30 days

Study Arms (2)

wIRA irradiation

ACTIVE COMPARATOR

Patients in Group A received local water-filtered infrared A (wIRA) irradiation once for 20 min preoperatively.

Device: wIRA irradiation

visible light only

SHAM COMPARATOR

Patients assigned to Group B only received normal visible light application for 20 min prior to surgery.

Other: visible light only

Interventions

wIRA irradiationDEVICE

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

Also known as: wIRA (Hydrosun® radiator; Hydrosun Medizinaltechnik, Müllheim, Germany)
wIRA irradiation
visible light onlyOTHER

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

Also known as: Standard light bulb with visible normal conventional light.
visible light only

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar der Technischen Universität

Munich, Bavaria, 81675, Germany

Location

Related Publications (2)

  • 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.

    PMID: 16845694BACKGROUND

  • 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.

    PMID: 24169161DERIVED

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Beat M Künzli, MD

    Klinikum rechts der Isar, Technische Universität München, Munich, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. Dr. med.

Study Record Dates

First Submitted

July 22, 2012

First Posted

August 1, 2012

Study Start

August 1, 2008

Primary Completion

June 1, 2010

Study Completion

July 1, 2012

Last Updated

September 6, 2012

Record last verified: 2012-09

Locations

DE(1)