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

NCT01722994 | Completed Phase 4 Results

• 1 other identifier: 2012-0180
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Closure Technique

Outcome Measures

Primary Outcomes (2)

• Presence of Scarring

  All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).

  1 week

• Presence of Scarring

  All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).

  3 weeks

Secondary Outcomes (3)

• Length of Time Till Absorbable Suture Fall Out

  3 weeks

• Presence of Infection

  1 week

• Presence of Infection

  3 weeks

Study Arms (2)

Group 1 Punch Biopsy Wound with chromic gut suture

EXPERIMENTAL

One of two absorbable sutures is used to close punch wounds.

Device: Chromic Gut Sterile absorbable Suture (Ethicon)

Group 2 Punch Biopsy Wound with PDS

EXPERIMENTAL

This is one of two absorbable sutures used to close punch biopsy wounds.

Device: Polyglactin 910 sterile synthetic absorbable suture (Ethicon)

Interventions

Polyglactin 910 sterile synthetic absorbable suture (Ethicon) DEVICE

Half of punch biopsy wounds are closed with each absorbablesuture

Group 2 Punch Biopsy Wound with PDS

Chromic Gut Sterile absorbable Suture (Ethicon) DEVICE

Group 1 Punch Biopsy Wound with chromic gut suture

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (5)

• 2. Habif TP. Clinical Dermatology: A Color Guide to Diagnosis and Therapy, 5th ed. Philadelphia, Pa: Mosby; 2010: 1006.

  BACKGROUND

• 4. Lammers, RL. Methods of Wound Closure. In Roberts JR, Hedges JR. Clinical Procedures in Emergency Medicine, 5th ed. Philadelphia, PA: Saunders Elsevier. 2009:592-633

  BACKGROUND

• Bennett RG. Selection of wound closure materials. J Am Acad Dermatol. 1988 Apr;18(4 Pt 1):619-37. doi: 10.1016/s0190-9622(88)70083-3.

  PMID: 3286691 BACKGROUND

• Gabel EA, Jimenez GP, Eaglstein WH, Kerdel FA, Falanga V. Performance comparison of nylon and an absorbable suture material (Polyglactin 910) in the closure of punch biopsy sites. Dermatol Surg. 2000 Aug;26(8):750-2; discussion 752-3. doi: 10.1046/j.1524-4725.2000.00049.x.

  PMID: 10940061 RESULT

• Christenson LJ, Phillips PK, Weaver AL, Otley CC. Primary closure vs second-intention treatment of skin punch biopsy sites: a randomized trial. Arch Dermatol. 2005 Sep;141(9):1093-9. doi: 10.1001/archderm.141.9.1093.

  PMID: 16172305 RESULT

Results Point of Contact

• Title: Dr. Robert Brodell
• Organization: University of Mississippi Medical Center

rbrodell@umc.edu

601-815-8000

Study Officials

• Robert T Brodell, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Division of Dermatology

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 7, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 2, 2016
• Results First Posted: March 2, 2016

Record last verified: 2016-02

Locations

US (1)