Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure

Scarring Clinical Trial

Official title:

Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06448481
• Other study ID #: 2136552
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 30, 2024
• Est. completion date: July 30, 2026

Study information

• Verified date: May 2024
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether intra-dermal versus transcutaneous purse-string closures have similar scar cosmesis and post-operative complications. The investigators will use a split wound model, where half of the wound will be closed with intra-dermal purse-string sutures and the other half will be closed with a transcutaneous purse-string sutures. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. Any adverse events will also be recorded.

Description:

The purse-string closure is a versatile technique that utilizes circumferential tissue advancement for partial or complete closure of circular cutaneous surgical defects. First reported in the 1950s for closure of a malar defect, the purse-string closure is now routinely used for umbilical, urethral, and breast defects as well as for cutaneous surgical defects either alone or in conjunction with top sutures, local flaps, or grafts. Though the purse-string closure was initially described with circumferentially placed intradermal sutures, various modifications to this technique have been published including sub-cuticular, intra-dermal, and cuticular variations. All modifications of the purse-string closure share the advantages of reduced operating time, decreased defect and scar size, no removal of normal tissue, low hematoma risk, and faster healing time. However, several papers suggest that cuticular (transcutaneous) purse-string closures may be superior to intra-dermal purse-string closures due to enhanced hemostasis from greater compression of the dermal vessels, greater utility in atrophic and actinically damaged skin, lower risk of dermal dehiscence, and better efficacy in skin with limited laxity. In 2015, a randomized trial comparing secondary intention healing to intradermal purse-string closure found similar cosmetic outcomes, scar size and pain level between the intra-dermal purse-string closure and secondary intention healing however similar studies comparing intra-dermal and transcutaneous purse-string closures are lacking. Given the potential functional advantages of the transcutaneous purse-string closure over the intra-dermal purse-string closure, additional studies comparing the two variations of the purse-string closure are needed to guide clinical practice. The aesthetic outcome and rate of post-operative complications of intra-dermal versus transcutaneous purse-string closures have not been studied. This study seeks to compare the effectiveness of transcutaneous purse-string sutures to intra-dermal purse-string sutures by using individuals as their own controls in a split-scar model.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 73
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older
• Able to give informed consent themselves
• Patient scheduled for cutaneous surgical procedure on the head, neck, trunk, or extremities with predicted purse-string closure.
• Willing to return for follow up visit

Exclusion Criteria:

• Incarceration
• Under 18 years of age
• Pregnant Women

Related Conditions & MeSH terms

• Cicatrix
• Scarring

Intervention

Procedure:
• Intra-dermal purse-string closure
Sutures are placed below the skin surface around a circular surgical wound, and the ends are cinched together like a coin purse.
• Transcutaneous purse-string closure
Sutures are placed through the skin surface around a circular surgical wound, and cinched together like a coin purse.

Locations

Country	Name	City	State
United States	University of California, Davis - Dermatology Department	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (9)

Cohen PR, Martinelli PT, Schulze KE, Nelson BR. The cuticular purse string suture: a modified purse string suture for the partial closure of round postoperative wounds. Int J Dermatol. 2007 Jul;46(7):746-53. doi: 10.1111/j.1365-4632.2007.03253.x. — View Citation

Cohen PR, Martinelli PT, Schulze KE, Nelson BR. The purse-string suture revisited: a useful technique for the closure of cutaneous surgical wounds. Int J Dermatol. 2007 Apr;46(4):341-7. doi: 10.1111/j.1365-4632.2007.03204.x. — View Citation

Fioramonti P, Sorvillo V, Maruccia M, Lo Torto F, Marcasciano M, Ribuffo D, Cigna E. New application of purse string suture in skin cancer surgery. Int Wound J. 2018 Dec;15(6):893-899. doi: 10.1111/iwj.12941. Epub 2018 Jun 29. — View Citation

Joo J, Custis T, Armstrong AW, King TH, Omlin K, Kappel ST, Eisen DB. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial. JAMA Dermatol. 2015 Mar;151(3):265-70. doi: 10.1001/jamadermatol.2014.2313. — View Citation

Lam TK, Lowe C, Johnson R, Marquart JD. Secondary Intention Healing and Purse-String Closures. Dermatol Surg. 2015 Oct;41 Suppl 10:S178-86. doi: 10.1097/DSS.0000000000000480. — View Citation

Park S, Oh Y, Lee JW, Choi S, Nam KA, Roh MR, Chung KY. Various Applications of Purse-String Suture and Its Cosmetic Outcome in Cutaneous Surgical Defects. Ann Dermatol. 2023 Apr;35(2):100-106. doi: 10.5021/ad.21.263. — View Citation

Raposio E, Antonacci M, Caruana G. A simple technique for the excision of cutaneous carcinoma: the round block purse-string suture. World J Surg Oncol. 2014 Aug 20;12:263. doi: 10.1186/1477-7819-12-263. — View Citation

Scholl L, Meier NM, Hessam S, Valavanis K, Bechara FG. Subcuticular and cuticular purse-string sutures in dermatologic surgery. J Dtsch Dermatol Ges. 2016 Feb;14(2):196-8. doi: 10.1111/ddg.12896. Epub 2016 Jan 20. No abstract available. — View Citation

Weisberg NK, Greenbaum SS. Revisiting the purse-string closure: some new methods and modifications. Dermatol Surg. 2003 Jun;29(6):672-6. doi: 10.1046/j.1524-4725.2003.29160.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)	The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.	3 months
Secondary	Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)	This is the patient portion of the POSAS assessment, which will be independently recorded. The patient scale of the POSAS consists of six items (pain, itch, thickness, color, stiffness, and irregularity). All items are scored on a scale ranging from 1 ("as normal skin") to 10 ("yes, very different"). The sum of the six items results in a total score of the POSAS patient scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.	3 months
Secondary	Width of Scar as measured using Trace-to-Tape Method	The trace-to-tape method is an objective measure for linear postoperative scars. The mean scar width will be determined using the trace-to-tape method. The surface area of the scar will be collected by tracing the scar with a water-based gel pen. While still wet, the gel residue will be lifted from the skin with clear packing tape and transferred on a sheet of paper.	3 months
Secondary	Complications or Adverse Events from Treatment	For example, if one half of the scar has more associated erythema, as measured using the Trace-to-Tape method, then it will be recorded. Other complications from the treatment will also be recorded.	3 months