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Polyglactin 910 vs Poligelecaprone 25 Running Subcuticular Closure of Elliptical Excision Wounds

NCT02776618 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-05-17

No results posted yet for this study

Summary

We will be recruiting patients requiring excisions of skin cancer and comparing aesthetic and functional differences of suture repair of excisional defects using polyglactin 910 vs poliglecaprone 25 with a split-scar model. Excision sites will be on either the trunk or extremities. Standard dermatological excision and repair methods will be used for removal of lesions and repair of the wound by surgeons; training courses will be used to limit inter-surgeon variation in technique. Excisional defects will be repaired with deep polyglactin 910 sutures, followed by randomly assigned subcuticular closure of one half of the defect with polyglactin 910 sutures and the other half with poliglecaprone 25 sutures. The patient will follow-up at 6 months and fill out a patient self-assessment evaluation survey of the scar. Photographs will also be taken of the scars at the follow-up at 6 months, which will be then be assigned to a set of blinded observers to evaluate the wound using a modified Patient Observer Self-Assessment Scale (mPOSAS). These observers will rate each scar on the mPOSAS scale and values will be averaged between observers. Total duration of participation will be 6 months, with 2 total visits (excision visit and follow-up visit).

Conditions

  • Cosmetics, Suture, Cicatrix

Interventions

PROCEDURE

running subcuticular closure of excisional defect

Excisional defects will be repaired with deep polyglactin 910 sutures, followed by each half of the wound given randomly assigned subcuticular superficial closure as described in the treatment arms.

Sponsors & Collaborators

Principal Investigators

  • Scott D Worswick, MD · Univeristy of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-15
Primary Completion
2017-05-15
Completion
2017-05-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02776618 on ClinicalTrials.gov