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SurgeryNCT03001856

Interrupted Oblique Intradermal Suture Versus Conventional Interrupted Intradermal Suture

A study testing Oblique Intradermal Suture and Intradermal Suture in people with Surgery, run by Mae Fah Luang University Hospital.

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

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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Surgery
What is being tested?
Oblique Intradermal Suture and Intradermal Suture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
No sites listed yet
Study dates
Jan 2016to Dec 2016
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • needs elective surgery with linear incision wound
  • wound length must be 3-12 cm.

Who cannot join

  • irregular wound shape
  • asymmetrical wound depth
  • different skin color in wound area
  • contaminated wound
  • mental impairment
  • pregnancy
  • patients with soft tissue disease

About this study

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

Read the detailed description

Bi-layered skin closure is one of the most common methods for closing cutaneous defects. The deep layer is closed with a conventional interrupted intradermal suture using absorbable materials, while the superficial layer is approximated with simple interrupted or simple continuous suture using non-absorbable materials. The cosmetic result of bi-layered closure is better than simple interrupted suture alone, because the interrupted intradermal suture component plays a major role in reducing wound tension, which has the effect of minimizing suture marks. Although the advantages of bi-layered closure are recognized, bi-layered closure is often not used in favor of simple interrupted suture due to the fact that interrupted intradermal suture is time consuming and more suture material is required. Thus, if an intradermal suturing technique can be identified that takes less time and requires less material while yielding a similar cosmetic result, patients would have more opportunity to receive bi-layered closure and obtain a better wound outcome.

Several novel intradermal suturing techniques could be alternative to the conventional interrupted intradermal suture technique, including buried butterfly suture, double butterfly suture, subcutaneous inverted cross mattress suture, and interrupted oblique intradermal suture. Among these novel techniques, interrupted oblique intradermal suture (OIS) is recognized for its relative simplicity. OIS is easy to perform, even for beginners. The simplicity and effectiveness of OIS increase its potential of becoming one of the standard suturing techniques in medical practice.

OIS is very similar to conventional interrupted intradermal suture (IS), except that the suture in OIS is canted or angled relative to the vertical plane. 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. The key characteristic that distinguishes OIS from IS is that OIS involves suturing on an angle to the vertical plane and IS involves suturing on the vertical plane.

In theory, OIS is a hybrid method that combines IS and buried horizontal butterfly suture. OIS combines the ability of IS to reduce tension at the wound edge and the ability of horizontal butterfly suture to provide good wound edge apposition and eversion. Because OIS is canted, it can provide tension in both the vertical and horizontal planes. Moreover, 1 stitch of OIS should yield wound closure approximately equal to that of 2 stitches of IS due to the same horizontal distance between 1 OIS stitch and 2 VIS stitches. Accordingly, it can be inferred that OIS should result in a 50% reduction in both suturing time and suturing material used.

However, OIS has the same obstacle as many other novel suturing techniques that there is very little literature to support OIS clinically which makes usage and generalization of TIS remain limited. It was hypothesized that OIS is equivalence to IS in wound outcome while consumes less time and less suture material. This study aims to demonstrate the equivalence of wound outcomes between the interrupted oblique intradermal suture (OIS) and conventional interrupted intradermal suture (IS) methods.

Conditions
Surgery
Being tested
Oblique Intradermal Suture, Intradermal Suture

What participants receive

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

  • Oblique Intradermal SutureProcedure or surgery

  • Intradermal SutureProcedure or surgery

Study groups in NCT03001856
Study groupRoleWhat they receive
Oblique Intradermal SutureExperimentalOIS 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.
Receives: Procedure: Oblique Intradermal Suture
Intradermal SutureExperimentalConventional interrupted intradermal suture
Receives: Procedure: Intradermal Suture

What is being measured

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

  1. Modified Hollander Cosmesis Scale (MHCS) at 1st week

    Wound evaluation at 1st week

    Measured: 1 week

  2. Patient and Observer Scar Assessment Scale (POSAS) at 1st week

    Wound evaluation at 1st week

    Measured: 1 week

  3. Modified Hollander Cosmesis Scale (MHCS) at 2nd month

    Wound evaluation at 2nd month

    Measured: 2nd month

  4. Patient and Observer Scar Assessment Scale (POSAS) at 2nd month

    Wound evaluation at 2nd month

    Measured: 2nd month

Secondary outcomes (5)
  1. Rate of wound dehiscence

    Measured: 1 week

  2. Rate of wound infection

    Measured: 1 week

  3. Suture time

    Measured: day 1

  4. Number of stitches

    Measured: day 1

  5. Suture material length

    Measured: day 1

Timeline

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

  1. First posted23 Dec 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03001856
Sponsor's protocol ID
MaeFahLuangUH
Status last verified
Jan 2017
First submitted
19 Dec 2016
Last updated
10 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30380956

Questions about this trial

What is this clinical trial studying?

A study testing Oblique Intradermal Suture and Intradermal Suture in people with Surgery, run by Mae Fah Luang University Hospital.

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 7 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 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Modified Hollander Cosmesis Scale (MHCS) at 1st week (time frame: 1 week). The study lists 4 primary outcomes in all. 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 NCT03001856, which also lists 1 linked publication.

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 10 Jan 2017.

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