NCT06638736

Brief Summary

The study aims to compare outcomes in patient comfort, cosmetic appearance, and complication rates between sutures and staples in high tension areas for closures of skin cancers excised in a dermatology clinic.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

July 1, 2020

Last Update Submit

October 10, 2024

Conditions

SurgerySkin CancerSuture; Complications, Infection or Inflammation

Outcome Measures

Primary Outcomes (6)

  • Scored cosmetic appearance by blinded physician

    A blinded physician will grade the cosmetic appearance of the scar using a visual analog scale and Vancouver scar scale

    2 weeks post procedure

  • Scored cosmetic appearance by blinded physician

    A blinded physician will grade the cosmetic appearance of the scar using a visual analog scale and Vancouver scar scale

    6 months post procedure

  • Scored cosmetic appearance by patient

    The patient will grade the cosmetic appearance of the scar using a visual analog scale

    2 weeks post procedure

  • Scored cosmetic appearance by patient

    The patient will grade the cosmetic appearance of the scar using a visual analog scale

    6 months post procedure

  • Patient self reported comfort with placement of either sutures or staples

    Patients will fill out a survey after either suture or staple placement to assess how comfortable placement of the sutures or staples was. They will be asked to rate questions related to their comfort on a scale of 1-10.

    at time of surgery

  • Patient self reported comfort with removal of either sutures or staples

    Patients will fill out a survey after either suture or staple removal to assess how comfortable the removal of the sutures or staples was. They will be asked to rate questions related to their comfort on a scale of 1-10.

    2 weeks after placement

Secondary Outcomes (1)

  • Number and types of complications reported

    procedure until 6 month follow up

Study Arms (2)

Suture group

OTHER

1/2 of the total number of patients will be randomized into the suture group (excision wound will be closed with suture), the intervention is the method of closure (sutures or staples)

Other: Wound Closure with sutures vs staples

Staples group

OTHER

1/2 of the total number of patients will be randomized into the staples group (excision wound will be closed with staples), the intervention is the method of closure (sutures or staples)

Other: Wound Closure with sutures vs staples

Interventions

Wound Closure with sutures vs staplesOTHER

Closure of the wound with either sutures or staples depending upon the study arm

Staples groupSuture group

Eligibility Criteria

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

You may qualify if:

  • and over
  • Willing to return to KU for follow up clinic visits on at least 2 occasions
  • Lesion location on high tension area as defined by: back, shoulder, scapula, elbow, scalp
  • Incisions between the lengths of 3cm to 12 cm
  • Skin pathology as defined by BCC, SCC, Melanoma
  • No known history of keloid or excessive scar formation
  • No known contraindication or skin sensitivity to suture or staple material
  • No contraindication to lidocaine with epinephrine

You may not qualify if:

  • \<18 years old
  • Non english speaking
  • Needs surrogate decision maker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • Sharma C, Verma A, Soni A, Thusoo M, Mahajan VK, Verma S. A randomized controlled trial comparing cosmetic outcome after skin closure with 'staples' or 'subcuticular sutures' in emergency cesarean section. Arch Gynecol Obstet. 2014 Oct;290(4):655-9. doi: 10.1007/s00404-014-3274-9. Epub 2014 May 11.

    PMID: 24816689BACKGROUND

  • Fayssoux K, Mahmood R, Grindle J, Nass S. Staples vs. Sutures After Cesarean Delivery. Am Fam Physician. 2018 Jul 1;98(1):50. No abstract available.

    PMID: 30215963BACKGROUND

MeSH Terms

Conditions

Skin NeoplasmsInfectionsInflammation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Physician evaluating scars post closure will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomize into either the suture group or staple group for closure
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

October 15, 2024

Study Start

July 1, 2020

Primary Completion

June 1, 2021

Study Completion

October 10, 2024

Last Updated

October 15, 2024

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)