Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial
COSTA
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study was to investigate the effect of 'muscle sparing technique' while harvesting costal/rib cartilage on postoperative donor-site morbidity -namely postoperative pain. Although authors report 'muscle sparing technique' cause less pain its not investigated in an evidence-based-medicine perspective. Therefore the investigators are planning a controlled, prospective clinical trial to compare the conventional method and 'muscle sparing technique'. Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 17, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJune 30, 2016
June 1, 2016
5 months
June 17, 2016
June 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Postoperative Pain
Postoperative pain and its change from baseline to 45th postoperative day will be evaluated with Visual Analogue Scale
Postoperative first 45 days
Study Arms (2)
Muscle-sparing
ACTIVE COMPARATORFollowing skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were passed with blunt dissection. Muscle fibers were dissected parallel to their positioning.
Muscle-cutting
ACTIVE COMPARATORFollowing skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were cut with Monopolar electrocautery at (25 watts).
Interventions
Eligibility Criteria
You may qualify if:
- Revision rhinoplasty
- when costal cartilage is harvested full-thickness
You may not qualify if:
- Fibromyalgia
- No consent
- When patient does not comply with follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology
Istanbul, Gaziosmanpasa, 00000, Turkey (Türkiye)
Related Publications (2)
Fedok FG. Costal Cartilage Grafts in Rhinoplasty. Clin Plast Surg. 2016 Jan;43(1):201-12. doi: 10.1016/j.cps.2015.08.002. Epub 2015 Oct 24.
PMID: 26616708BACKGROUNDCochran CS. Harvesting Rib Cartilage in Primary and Secondary Rhinoplasty. Clin Plast Surg. 2016 Jan;43(1):195-200. doi: 10.1016/j.cps.2015.09.018. Epub 2015 Oct 23.
PMID: 26616707BACKGROUND
Study Officials
- STUDY DIRECTOR
Berke Ozucer, MD
Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment
- PRINCIPAL INVESTIGATOR
Mehmet E Dinc, MD
Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Otolaryngologist
Study Record Dates
First Submitted
June 17, 2016
First Posted
June 30, 2016
Study Start
February 1, 2016
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
June 30, 2016
Record last verified: 2016-06