Comparing 1 Week Versus 2 Week Cutaneous Suture Removal

NCT05267002 | Unknown

• 1 other identifier: 9728
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Our goal is to compare the difference in surgical outcomes and patient satisfaction for surgical scars on the face between suture removal at 1 week versus 2 weeks. There is variation in the timing at which Mohs surgeons remove sutures on the face. Some prefer 1 week, and others prefer 2 weeks. This has not been formally studied. It is possible the outcomes are the same between both groups, or that one has a better cosmetic outcome than the other. Your skin cancer will be removed as usual. After this, your wound will be sutured in the usual fashion, except the top sutures will be divided into two separate halves. You will return at 1 week for one half of the top sutures to be removed, and at 2 weeks for the other half to be removed. Which half is removed first will be determined at random at your 1 week visit. At two months, you will return for standardized photographs which will be used by physicians to rate the cosmetic outcomes of the wound halves based on a standardized scale. Most likely, there will be no difference between the wound halves at 2 months and the study is complete. There is a small chance that there will be a cosmetic difference seen at 2 months, in which case you will return at 1 year for repeat standardized photographs and ratings. All data and photographs will be kept secure and any identifying information will be destroyed at the end of the study.

Conditions

Suture; Complications, Mechanical; Scar; Surgery

Outcome Measures

Primary Outcomes (1)

• Scar Cosmesis Assessment and Rating scale (SCAR) score

  1\. Scar Cosmesis Assessment and Rating scale (SCAR), rated by three blinded observers based on digital photographs, with each half of the scar scored separately. This is a 0-13 rating with 0 representing the best possible scar.

  2months (and possibly one year, see protocol)

Secondary Outcomes (6)

• pain level with suture removal

  measured at 1 and 2 weeks after suture removal

• difficulty of suture removal

  measured at 1 and 2 weeks

• Patient scar satisfaction

  At 2 months

• Patient preference for 1 vs 2 week suture removal.

  Asked at 2 months

• Presence of suture tracks

  2 months

Study Arms (2)

Suture removal at 1 week

EXPERIMENTAL

Cutaneous nylon suture removal of half of the split-scar at one week.

Procedure: Suture removal timing

Suture removal at 2 weeks

EXPERIMENTAL

Cutaneous nylon suture removal of half of the split-scar at two weeks.

Procedure: Suture removal timing

Interventions

Suture removal timing PROCEDURE

Cutaneous nylon suture removal of each half of the split-scar at one and two weeks.

Suture removal at 1 week; Suture removal at 2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• intermediate or complex layered closures measuring 2.6-7.5 cm on the face (including the forehead, temples, nose, cheeks, chin)
• Wound edges must be able to be approximated with subcutaneous sutures. iii. Ability to follow up at 1 week, 2 weeks, 2 months, and 1 year iv. Participants able to be enrolled at time of wound repair.

Sponsors & Collaborators

• DermSurgery Associates: lead

Study Sites (1)

DermSurgery Associates

Houston, Texas, 77030, United States

RECRUITING

Related Publications (5)

• Eisen DB, Zhuang AR, Hasan A, Sharon VR, Bang H, Crispin MK. 5-0 Polypropylene versus 5-0 fast absorbing plain gut for cutaneous wound closure: a randomized evaluator blind trial. Arch Dermatol Res. 2020 Apr;312(3):179-185. doi: 10.1007/s00403-019-02009-5. Epub 2019 Nov 13.

  PMID: 31724097 BACKGROUND

• Yag-Howard C. Sutures, needles, and tissue adhesives: a review for dermatologic surgery. Dermatol Surg. 2014 Sep;40 Suppl 9:S3-S15. doi: 10.1097/01.DSS.0000452738.23278.2d.

  PMID: 25158874 BACKGROUND

• Gal P, Toporcer T, Vidinsky B, Hudak R, Zivcak J, Sabo J. Simple interrupted percutaneous suture versus intradermal running suture for wound tensile strength measurement in rats: a technical note. Eur Surg Res. 2009;43(1):61-5. doi: 10.1159/000219214. Epub 2009 May 19.

  PMID: 19451720 BACKGROUND

• Joo JS, Zhuang AR, Tchanque-Fossuo C, Tartar D, Armstrong AW, King TH, Sivamani RK, Eisen DB. Dermal suture only versus layered closure: A randomized, split wound comparative effectiveness trial. J Am Acad Dermatol. 2019 Dec;81(6):1346-1352. doi: 10.1016/j.jaad.2019.08.040. Epub 2019 Aug 21.

  PMID: 31442535 BACKGROUND

• Kantor J. Reliability and Photographic Equivalency of the Scar Cosmesis Assessment and Rating (SCAR) Scale, an Outcome Measure for Postoperative Scars. JAMA Dermatol. 2017 Jan 1;153(1):55-60. doi: 10.1001/jamadermatol.2016.3757.

  PMID: 27806156 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leonard H Goldberg, MD

  DermSurgery Associates

  STUDY DIRECTOR

Central Study Contacts

Remi Hamel, MD

CONTACT

713.791.9966; mariam@dermsurgery.org

Maria Hartley

CONTACT

713.791.9966; mariam@dermsurgery.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome will be the Scar Cosmesis Assessment and Rating scale (SCAR) score, with photographic assessment by three blinded fellowship-trained board-certified Mohs surgeons who were not involved with the original surgery or wound repair.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split Scar Study

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 4, 2022
• Study Start: February 24, 2022
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)