Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure
NCT ID: NCT06448481
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
73 participants
INTERVENTIONAL
2025-12-01
2027-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intra-dermal purse-string closure on Side A
For all participants, one wound side half will be labeled as A and the other side as B. Side A will be closed with a intra-dermal purse-string closure, and Side B will be closed with a transcutaneous purse-string closure.
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.
Intra-dermal purse-string closure on Side B
For all participants, one wound side half will be labeled as A and the other side as B. Side B will be closed with a intra-dermal purse-string closure, and Side A will be closed with a transcutaneous purse-string closure.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Under 18 years of age
* Pregnant Women
18 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Daniel Eisen, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis - Dermatology
Locations
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University of California, Davis - Dermatology Department
Sacramento, California, United States
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2136552
Identifier Type: -
Identifier Source: org_study_id
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