Phase 4
N=97
A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites
Wound Closure Technique
Bottom Line
View on ClinicalTrials.gov: NCT01722994 ↗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
| Outcome | Result | p-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
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.