NCT01770002

Brief Summary

The investigators hypothesize that everting wound edges while suturing surgical sites will result in more aesthetic scars. Additionally, we also hypothesize that small to moderate wound irregularities present at 3 months will resolve by 6 months after surgery with no intervention

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

January 15, 2013

Last Update Submit

April 15, 2015

Conditions

Basal Cell CarcinomaSquamous Cell CarcinomaMelanoma

Outcome Measures

Primary Outcomes (9)

  • Everted versus non-everted suturing techniques

    Primary outcome measures for this study are the post operative scar width measured at 1 cm from the midline on both sides of the scar.

    3 and 6 months

  • Mean score of sum of 2 blinded observers POSAS scores

    The mean summed total of two blinded reviewers Physician Observer Scar Assessment Scale (POSAS) scores for each side of the wound.

    3 and 6 months

  • Scar measurements (height, width, length)

    Scar volume will be measured in centimeters on both sides of the wound

    3 and 6 months

  • Scar induration

    Scar induration area will be measured in centimeters for both sides of the wound

    3 and 6 months

  • Scar erythema

    Scar erythema area will be measured in centimeters for both sides of the wound

    3 and 6 months

  • Wound contour irregularities

    Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement

    3 and 6 months

  • Stand cone volume

    The volume of standing cones will be measured via length, width and height measurements in centimeters

    3 and 6 months

  • Uneven edge measurement

    The area of uneven edges will be measured via a length x height measurement in centimeters

    3 and 6 months

  • Hyperpigmentation area

    areas of hyperpigmentation will be measured via a length x width measurement in centimeters

    3 and 6 months

Secondary Outcomes (3)

  • Infection

    up to 6 months

  • wound dehiscence

    up to 6 months

  • spitting sutures

    3 and 6 months

Study Arms (2)

Everted suture technique

ACTIVE COMPARATOR

Technique that everts the skin; the edges will sit up against each other in a little peak, raised above the surrounding skin.

Procedure: Everted suture technique

Non-everted suture technique

ACTIVE COMPARATOR

Surgical wound will be approximated such that the suture line is flat relative to the surrounding skin.

Procedure: Non-everted suture technique

Interventions

Everted suture techniquePROCEDURE
Everted suture technique
Non-everted suture techniquePROCEDURE
Non-everted suture technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • Able to give informed consent themselves
  • Willing to return for follow up visits

You may not qualify if:

  • Mentally handicapped
  • Unable to understand written and oral English
  • Incarceration
  • Under 18 years of age
  • Unwilling to return for follow up
  • Pregnant Women
  • Wounds less than 3 cm in length

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Basal CellCarcinoma, Squamous CellMelanoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms, Squamous CellNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Daniel Eisen, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

US(1)