Clinical trial NCT06448481: Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure
Official title: Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Scarring
Keywords: Purse-string
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
timeFrame: 3 months
Secondary outcomes:
measure: Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
timeFrame: 3 months
measure: Width of Scar as measured using Trace-to-Tape Method
timeFrame: 3 months
measure: Complications or Adverse Events from Treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis - Dermatology Department
state: California
Study officials:
affiliation: University of California, Davis - Dermatology
name: Daniel Eisen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.
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.
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.
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.