NCT01977612

Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Completed Phase 2 Results posted Last updated 31 July 2017

What this trial tests

Phase 2 trial testing 4-0 monofilament suture in Wound Infection in 173 participants. Completed in 30 June 2016.

Timeline

15 May 2013

Primary endpoint
17 June 2016

30 June 2016

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	173
Start date	15 May 2013
Primary completion	17 June 2016
Estimated completion	30 June 2016
Sites	1 location across United States

Drugs / interventions tested

• 4-0 monofilament suture
• Stainless steel staples

Conditions studied

• Wound Infection — all drugs for Wound Infection →
• Wound Complication — all drugs for Wound Complication →

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 85, female only, with Wound Infection or Wound Complication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. Primary · 4-8 weeks post-surgery

Group	Value	95% CI
Stainless Steel Staples	28
4-0 Monofilament Sutures	25

Incidence of Wound Disruption Secondary · 4-8 weeks post-surgery

Group	Value	95% CI
Stainless Steel Staples	21
4-0 Monofilament Sutures	13

Incidence of Wound Infection Secondary · 4-8 weeks post-surgery

Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.

Group	Value	95% CI
Stainless Steel Staples	1
4-0 Monofilament Sutures	1

Operative Time Secondary · During surgery

Time from skin incision to the end of skin closure

Group	Value	95% CI
Stainless Steel Staples	3	2 – 4
4-0 Monofilament Sutures	11	9 – 15

Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score Secondary · 4-8 weeks post-operative

* Ranges from 0 (worst) to 5 (best) * Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0

Group	Value	95% CI
Stainless Steel Staples	4	3 – 5
4-0 Monofilament Sutures	5	4 – 5

Median Patient Satisfaction Score of Scar Appearance Secondary · 4-8 weeks post-operative

Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated "very unsatisfied" or 0% and the end of the line was "very satisfied" or 100%.

Group	Value	95% CI
Stainless Steel Staples	68	49 – 83
4-0 Monofilament Sutures	77	52 – 87

Sponsor's own description

Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Wound Complication Rates After Staples or Suture for Midline Vertical Skin Closure in Obese Women: A Randomized Controlled Trial.
   Kuroki LM, Mullen MM, Massad LS, Wu N, et al · · 2017 · cited 18× · PMID 28594761 · DOI 10.1097/aog.0000000000002061