Evaluation of a new wound closure device for linear surgical incisions: 3M Steri-Strip S Surgical Skin Closure versus subcuticular closure

Plast Reconstr Surg. 2010 Jan;125(1):186-194. doi: 10.1097/PRS.0b013e3181c2a492.

Abstract

Background: Technological innovations are often adopted before scientific comparison to an accepted standard. The authors' study compared suture with a new coaptive film device, 3M Steri-Strip S Surgical Skin Closure, on linear incisions.

Methods: Patients undergoing Wise-pattern breast reduction or abdominal procedures had paired incisions randomly assigned to Steri-Strip S or suture closure. Key outcome measures were closure time, patient comfort, and scar quality at 6 months by patients and surgeons using a new scar evaluation tool, visual assessment of linear scars. Statistical differences between the two closure techniques were assessed by Wilcoxon signed rank test.

Results: Of 59 patients, eight were excluded from randomization (a surgeon judged Steri-Strip S to be a nonviable closure technique for mismatched wound edges). Fifty-one patients (breast, n = 24; abdomen, n = 27) were randomized. Operative time with Steri-Strip S for breast was 2.0 minutes (SD = 1.1) versus suture closure at 4.6 minutes (SD = 1.5; p < 0.001). Similarly, Steri-Strip S versus suture for the abdomen was faster (p < 0.001; 4.9 minutes, SD = 2.3 versus 10.1 minutes, SD = 3.4). Comfort scores did not differ between closures [5.8 (SD = 2.7) versus 6.9 (SD = 2.0), respectively, on breast (p = 0.142) and 7.7 (SD = 1.8) versus 7.7 (SD = 2.3) on abdomen (p = 0.903)]. Complication rates did not differ between closure types. Patients' visual assessment of linear scars rating of breasts was 3.8 (SD = 2.9) for Steri-Strip S and better at 2.6 (SD = 2.9) for suture (p = 0.008). One surgeon rated breast Steri-Strip S scars worse than suture scars (4.3 versus 3.7; p = 0.014). For abdominal scars, there was no difference in the patient or surgeon ratings.

Conclusions: Steri-Strip S permits faster wound closure than suture. On the basis of patient reports of comfort and scar quality, surgeons increase efficiency and maintain quality with the use of Steri-Strip S on abdominal wounds but not on breast wounds.

Trial registration: ClinicalTrials.gov NCT00727025.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdomen / surgery
  • Abdominal Muscles / surgery
  • Bandages*
  • Cicatrix
  • Clinical Competence
  • Equipment Design
  • Female
  • Humans
  • Mammaplasty
  • Materials Testing
  • Sutures*
  • Time Factors
  • Tissue Adhesives / therapeutic use*
  • Wound Healing

Substances

  • Tissue Adhesives

Associated data

  • ClinicalTrials.gov/NCT00727025