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

University of California (UC) Davis

Status: Not yet enrolling

Conditions: Scarring

Treatments: Procedure: Transcutaneous purse-string closure; Procedure: Intra-dermal purse-string closure

Study type: Interventional

Funder types: Other

Identifiers

NCT06448481

2136552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

73 participants in 2 patient groups

Intra-dermal purse-string closure on Side A

Experimental group

Description:

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.

Treatment:

Procedure: Intra-dermal purse-string closure

Procedure: Transcutaneous purse-string closure

Intra-dermal purse-string closure on Side B

Experimental group

Description:

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.

Treatment:

Procedure: Intra-dermal purse-string closure

Procedure: Transcutaneous purse-string closure