Interrupted Oblique Intradermal Suture Versus Conventional Interrupted Intradermal Suture
1 other identifier
interventional
144
0 countries
N/A
Brief Summary
This study was conducted to demonstrate the equivalence of wound outcomes between the interrupted oblique intradermal suture (OIS) and conventional interrupted intradermal suture (IS) methods
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable surgery
Started Jan 2016
Shorter than P25 for not_applicable surgery
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
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 19, 2016
CompletedFirst Posted
Study publicly available on registry
December 23, 2016
CompletedJanuary 10, 2017
January 1, 2017
11 months
December 19, 2016
January 8, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Modified Hollander Cosmesis Scale (MHCS) at 1st week
Wound evaluation at 1st week
1 week
Patient and Observer Scar Assessment Scale (POSAS) at 1st week
Wound evaluation at 1st week
1 week
Modified Hollander Cosmesis Scale (MHCS) at 2nd month
Wound evaluation at 2nd month
2nd month
Patient and Observer Scar Assessment Scale (POSAS) at 2nd month
Wound evaluation at 2nd month
2nd month
Secondary Outcomes (5)
Rate of wound dehiscence
1 week
Rate of wound infection
1 week
Suture time
day 1
Number of stitches
day 1
Suture material length
day 1
Study Arms (2)
Oblique Intradermal Suture
EXPERIMENTALOIS is very similar to conventional interrupted intradermal suture (IS), except that the suture in OIS is canted or angled relative to the vertical plane (Figure 1). To perform OIS, the needle is passed from deep to superficial dermis and canted 30°-60° from the normal vertical plane. The needle is then inserted into the opposite wound edge from superficial to deep dermis in a mirror-image fashion. The thread is tied with a square knot to finish the suture.
Intradermal Suture
EXPERIMENTALConventional interrupted intradermal suture
Interventions
Eligibility Criteria
You may qualify if:
- years or older
- needs elective surgery with linear incision wound
- wound length must be 3-12 cm.
You may not qualify if:
- irregular wound shape
- asymmetrical wound depth
- different skin color in wound area
- contaminated wound
- mental impairment
- pregnancy
- patients with soft tissue disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Wongkietkachorn A, Wongkietkachorn N, Rhunsiri P. Oblique intradermal suture as a faster choice for intradermal closure: a randomized equivalence trial. J Plast Surg Hand Surg. 2019 Feb;53(1):45-50. doi: 10.1080/2000656X.2018.1533476. Epub 2018 Oct 31.
PMID: 30380956DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
December 19, 2016
First Posted
December 23, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 10, 2017
Record last verified: 2017-01