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Phase 4 N=97 Randomized Treatment

A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites

Wound Closure Technique

Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Presence of Scarring — 1; 1 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Polyglactin 910 sterile synthetic absorbable suture (Ethicon) (Device); Chromic Gut Sterile absorbable Suture (Ethicon) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Mississippi Medical Center
Primary completion
Sep 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Presence of Scarring
0; 1
PRIMARY
Presence of Scarring
0; 1
SECONDARY
Length of Time Till Absorbable Suture Fall Out
15.7; 20.2
SECONDARY
Presence of Infection
1; 0
SECONDARY
Presence of Infection
1; 0

Summary

Some Dermatologists prefer absorbable suture to non-absorbable suture in the closure of punch biopsy sites. The reason these are often preferred is because patients do not have to pay for another visit to get the suture material removed. Also patients are not inconvenienced into returning to the office for suture removal1. However, the absorbable suture material currently used by most Dermatologists is very expensive. In order to evaluate ways to reduce costs for patients, we will compare a less expensive suture material (chromic gut) with one of the absorbable suture materials currently used in clinical practice (PDS). Patients who are eligible and choose to participate in the study will undergo a punch biopsy and a suture will be used to close the skin. The type of suture received by the patient will be randomized, like the flip of a coin. Group A will receive PDS and Group B will receive chromic gut suture. After one weeks time, the patient will return to clinic and their dermatologist will evaluate the biopsy site for redness, wound infection, wound opening, and scar formation. The patients will be given a questionnaire evaluating their satisfaction with the cosmetic outcome and any pain caused by the suture materials. If the suture came out before the visit, the patient will be asked to report on what day the suture fell out. The patients will return two more times over the next two weeks to receive the same questionnaire and evaluation by their dermatologist.

Eligibility Criteria

Inclusion Criteria

  • Be age 18 or older
  • Having a punch biopsy procedure performed for benign reasons
  • Biopsy site is between the shoulders and ankles

Exclusion Criteria

  • Having a punch biopsy procedure performed for a suspicious cancerous lesion including basal and squamous cell carcinoma and melanoma
  • Biopsy site is on the face, palms, soles or groin area
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01722994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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