Phase 2
N=165
Randomized Clinical Trial of Skin Closure With Staples Versus Suture
Wound Infection · Wound Complication
Bottom Line
View on ClinicalTrials.gov: NCT01977612 ↗Enrolled (actual)
165
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. — 28; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 4-0 monofilament suture (Device); Stainless steel staples (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. |
28; 25 | — |
| SECONDARY Incidence of Wound Disruption |
21; 13 | — |
| SECONDARY Incidence of Wound Infection |
1; 1 | — |
| SECONDARY Operative Time |
3; 11 | — |
| SECONDARY Analog Pain Score on Postoperative Days 3-4 |
— | — |
| SECONDARY Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score |
4; 5 | — |
| SECONDARY Median Patient Satisfaction Score of Scar Appearance |
68; 77 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- All women, >=18 and =30
- Benign or oncologic indications for surgery.
- Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
- Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria
- Women who are pregnant or breastfeeding
- Pfannenstiel or transverse abdominal incision
- Concomitant panniculectomy or plastic surgery
- Women <18 years of age
- History of prior abdominal or pelvic radiation
- Inability to sign an informed consent form prior to registration on study
- Inability to understand spoken or written English
- Prisoner
- Mental incapacity
- A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.
Data sourced from ClinicalTrials.gov (NCT01977612). 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.