Trial document




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  DRKS00009790

Trial Description

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Title

Occlusive wound healing after endonasal endoscopic sinus surgery – a prospective randomized trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The main goal of the study is to compare wound healing after sinus surgery with occlusion of the nose and with standard open aftercare. We want to investigate if occlusive wound healing is quicker than open wound healing. The state of wound healing is examined 2, 3, 4, 12 weeks and 1 year after surgery.The duration of the cleaning of the nose and the size of the frontal and maxillary sinus ostium are also compared.
Aftercare after sinus surgery is necessary and important and improves the outcome. The aim of the aftercare is to improve wound healing and early regeneration of epithelium, to reduce local inflammation and patient symptoms in the early postsurgical phase. Usually the nose and sinuses are cleaned with instruments during the first days after surgery. Occlusion of the nose, e.g. temporary closure of the nose with a tape, is relatively new. It is recommended, as occlusion of wounds ensures a moist wound environment, which has a positive effect on wound healing. Occlusion prevents drying-out of superficial tissue layers which leads to superficial necrosis and drying-up of wound fluids. After sinus surgery study participants receive medical treatment for their sinus disease. They receive a steroid nasal spray and are asked to perform nasal douches. This treatment is independent of the study. Depending on which group the participants are randomized to, the nose will be cleaned regularly or a special tape is applied to the nose for 2 weeks. 2, 3, 4, 12 weeks and 1 year after surgery the wound healing is evaluated by the ENT surgeon at the hospital. In addition participants are asked to complete a questionnaire regarding their health condition.

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Brief Summary in Scientific Language

The aim of the randomized study is to compare the conventional postoperative aftercare after sinus surgery with daily debridement of the nose with occlusion of the nose. the following parameters are compared in a two armed study design: dynamics of wound healing, effort of aftercare for patient and surgeon, comfort for the patient. After endoscopic sinus surgery patients receive medical treatment independent of the group they are randomized to according to current guidelines. To achieve a homogenous group, only patients with chronic rhinosinusitis with nasal polyps are included in the study.They receive the following medical treatment:
- topical nasal steroid (2 x 2 puffs daily) for 12 months
- nasal douches 3 x daily
- antibiotics (cephalosoprin i.v. preoperatively, Doxycyclin 100 mg OD, if allergic Cotrim forte 2 x 960 mg for 10 days)
- systemic steroids (Prednisolon 20 for 10 days)
Patients within the first study arm are asked to occlude the nose for 2 weeks 24 hours a day with a special tape. The tape is temporarily removed to use the steroid spray and for nasal douching. After temporary removal of the tape the nose is cleaned with instruments 2, 3 and 4 weeks after surgery by the ENT surgeon. In Patients in the second study arm the nasal cavity is left open. The nose is debrided daily during the inpatient stay . Afterwards the nose is cleaned with instruments 2, 3 and 4 weeks after surgery by the ENT surgeon.
Primary outcome:
- sinunasal wound healing 2 weeks postoperatively according to endoscopic score by Valentine 2010.
Occlusion of the nose will lead to a faster wound healing after endoscopic sinus surgery.
Secondary outcome:
- Occlusive wound healing is more comfortable for the patient (measured by VAS)
- sinunasal wound healing after 2, 3, 4, 12 weeks and 1 year after surgery is improved according to endoscopic score by Valentine 2010
- the duration of each aftercare visit is reduced
- the maxillary and frontal sinus neo-ostium is greater with occlusion


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Organizational Data

  •   DRKS00009790
  •   2015/12/29
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  •   yes
  •   Approved
  •   332/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   J32.4 -  Chronic pansinusitis
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Interventions/Observational Groups

  •   - topical nasal steroid (2 x 2 puffs daily) for 12 months
    - nasal douches 3 x daily
    - antibiotics (cephalosoprin i.v. preoperatively, Doxycyclin 100 mg OD, if allergic Cotrim forte 2 x 960 mg for 10 days)
    - systemic steroids (Prednisolon 20 for 10 days)
    Occlusion of the nose for 2 weeks 24 hours a day. The tape is temporarily removed to use the steroid spray and for nasal douching. After temporary removal of the tape the nose is cleaned with instruments 2, 3 and 4 weeks after surgery by the ENT surgeon.
  •   - topical nasal steroid (2 x 2 puffs daily) for 12 months
    - nasal douches 3 x daily
    - antibiotics (cephalosoprin i.v. preoperatively, Doxycyclin 100 mg OD, if allergic Cotrim forte 2 x 960 mg for 10 days)
    - systemic steroids (Prednisolon 20 for 10 days)
    The nasal cavity is left open. The nose is cleaned daily during the inpatient stay . Afterwards the nose is cleaned with instruments 2, 3 and 4 weeks after surgery by the ENT surgeon.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   No
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Primary Outcome

Primary outcome: sinunasal wound healing 2 weeks postoperatively according to endoscopic score by Valentine 2010.
Hypothesis: Occlusion of the nose will lead to a faster wound healing after endoscopic sinus surgery.

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Secondary Outcome

Secondary outcome:
- patient comfort measured by VAS 2, 3, 4, 12 weeks and 1 year postoperatively
- sinunasal wound healing after 3, 4, 12 weeks and 1 year after surgery according to endoscopic score by Valentine 2010
- the duration of each aftercare visit in minutes 2, 3, 4 weeks postoperatively
-size of the maxillary and frontal sinus neo-ostium in mm 3 months and 1 year postoperatively meassured with 3 mm suction instrument

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Countries of Recruitment

  •   Germany
  •   Czech Republic
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/12/10
  •   174
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Age >/= 18 years
- bilateral endonasal endoscopic sinus surgery: maxillary sinusotomy, anterior and posterior ethmoidectomy, frontal sinus drainage Draf IIa
- chronic rhinosinusitis with nasal polyps not responding to medical treatment (at least topical steroids for 6 weeks, nasal douches, antibiotics for 3 weeks if indicated, systemic steroids if indicated)
- informed consent
- compliance with the study protocol

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Exclusion Criteria

- no consent
- diseases that affect wound healing (AIDS, cystic fibrosis, immune deficiency, neutropenia)
- coagulation disorders or anticoagulants up to 7 days preoperatively
- indications for sinus surgery other than CRSwNP

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Addresses

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    • HNO-KlinikUniklinik Freiburg
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • HNO-KlinikUniklinik Freiburg
    • Ms.  Dr.  Tanja  Hildenbrand 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • HNO-KlinikUniklinik Freiburg
    • Ms.  Dr.  Tanja  Hildenbrand 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • HNO-KlinikUniklinik Freiburg
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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