Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448481
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None