- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03327922
Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis
Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sutures are the standard of care in repairing cutaneous wounds. The majority of surgical reconstructions following a Mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep layer and a top layer. The deep layer dissolves naturally whereas the top layer must be removed.
This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter spacing between sutures. It is possible that fewer, more widely spaced sutures may leave more open space in the wound, leaving more tension to pull on those few sutures, possibly encouraging the wound to dehisce and make it harder to approximate the wound edges yielding a less cosmetically appealing scar compared to placing many closely approximated sutures which would decrease the tension and likely better approximate the wound edges yielding a more cosmetically appealing scar. On the other hand, we may find that suture spacing has no effect on wound cosmesis and that placing fewer, more widely spaced sutures is much more time efficient. The investigator may also find that the effect of suture spacing on wound cosmesis is dependent on wound tension. For example, perhaps the suture pacing would have no effect on the cosmesis of a wound under no tension, however, for a wound under high tension, it is possible that many closely approximated sutures would yield better cosmetic results for the reasons listed above.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95816
- University of California, Davis, Department of Dermatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure on the trunk and extremities with predicted primary closure
- Willing to return for follow up visit.
Exclusion Criteria:
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Pregnant Women
- Wounds with predicted closure length less than 4 cm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vicryl absorbable suture placed 2 cm apart
Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
|
Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
|
Experimental: Vicryl absorbable suture placed 1 cm apart
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
|
Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient and Observer Scar Assessment Scale - Reviewer 1
Time Frame: 3 months following procedure
|
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS).
The POSAS measures scar quality in all types of scars by evaluating visual (e.g.
color), tactile (e.g.
pliability) and sensory (e.g.
itch) characteristics of the scar from the perspective of the observer and patients.
Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60.
Low scores indicate better outcomes.
|
3 months following procedure
|
|
Patient and Observer Scar Assessment Scale - Reviewer 2
Time Frame: 3 months following procedure
|
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS).
The POSAS measures scar quality in all types of scars by evaluating visual (e.g.
color), tactile (e.g.
pliability) and sensory (e.g.
itch) characteristics of the scar from the perspective of the observer and patients.
Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60.
Low scores indicate better outcomes.
|
3 months following procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Width of Scar
Time Frame: 3 months following procedure
|
A secondary endpoint will include the width of the scar 1 cm from midline on each side
|
3 months following procedure
|
|
Complications
Time Frame: 3 months following procedure
|
Any complications including suture reaction, dehiscence, infection, necrosis, bleeding, and hematoma
|
3 months following procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1115591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Interrupted Subdermal Suture
-
Assiut UniversityNot yet recruitingKidney Transplant | Suture Techniques | Suture, Interrupted | Continuous Suture
-
Technische Universität DresdenCompleted
-
Allama Iqbal Teaching HospitalCompletedWound Infection, Surgical | Dehiscence of Laparotomy Wound | Laparotomy Closure After Abdominal Surgery | Suture, Interrupted | Continuous SuturePakistan
-
University of UtahTerminatedSubdermal Skin TighteningUnited States
-
RemovAid ASKarolinska Institutet; FHI 360; Mulago Hospital, UgandaCompleted
-
Universidad Científica del SurNew York UniversityUnknownSuture Adverse Reaction | Suture; Complications, Mechanical | Suture Failure During Surgical Operation | Suture Related Complication | Suture Rupture | Suture; Complications, Infection or Inflammation | Suture Line Infection
-
San Antonio Uniformed Services Health Education...CompletedSuture | Dermatology | Suture Dermatologic | Closure Technique | Mohs Micrographic Surgery | Absorbable, Coated Sutures | Suture Techniques
-
Wigmore ClinicWithdrawnSuture, Complication | Suture; Complications, Mechanical | Suture; Complications, Infection or InflammationArmenia
-
Universidade do Vale do SapucaiUnknownSuture, ComplicationBrazil
Clinical Trials on Vicryl absorbable suture
-
Temple UniversityWithdrawnLacerations | Injuries | WoundsUnited States
-
University of British ColumbiaCompleted
-
University of California, San FranciscoCentral California Faculty Medical GroupRecruiting
-
Ricardo RendonTerminatedKidney NeoplasmsCanada
-
Benha UniversityCompleted
-
University of MiamiNot yet recruitingProsthetic Joint Infection | Suture | Debridement With Prosthesis Retention | Prosthetic Joint Infections of Hip | Prosthetic Joint Infections of KneeUnited States
-
The Affiliated Hospital of Qingdao UniversityRecruitingSuture, ComplicationChina
-
University of CatanzaroUnknownPeripheral Vascular Disease
-
Barzilai Medical CenterCompletedCesarean SectionIsrael
-
Ain Shams UniversityCompleted