Clinical Trials Logo

Clinical 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

NCT number NCT03001856
Study type Interventional
Source Mae Fah Luang University Hospital
Status Completed
Phase N/A
Start date January 2016
Completion date December 2016

See also
  Status Clinical Trial Phase
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Recruiting NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Active, not recruiting NCT03432429 - Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Not yet recruiting NCT04774965 - The Effects of SlumberCurveā„¢ Following Rotator Cuff Surgery: A Randomized Control Trial N/A
Not yet recruiting NCT04893876 - The OPERa Study: Evaluating QoL After Rectal Cancer Surgery
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT04595695 - The Effect of Clear Masks in Improving Patient Relationships N/A
Completed NCT04059328 - Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A
Completed NCT03355547 - Observation of Atelectasis Using Lung Ultrasonography in Children Undergoing General Anesthesia: the Cohort Study for Evaluation of the Relationship Between the Incidence and Severity of Upper Respiratory Tract Infection and the Magnitude of Anesthesia-induced Atelectasis
Recruiting NCT03572348 - VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures. N/A
Completed NCT04251637 - Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery
Recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Completed NCT04647006 - Comparison of TOETVA and Conventional Thyroidectomy N/A
Completed NCT03339791 - Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial N/A
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease