Clinical trial · Interventional
A Randomized Controlled Trial Comparing Sutures vs Staples for High Tension Closures
NCT06638736CI-TRIAL-00081594withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative withdrawal, study was never approved by IRB
Summary
Brief summary (as posted)
The study aims to compare outcomes in patient comfort, cosmetic appearance, and complication rates between sutures and staples in high tension areas for closures of skin cancers excised in a dermatology clinic.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
| Suture; Complications, Infection or Inflammation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wound Closure with sutures vs staples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Suture group
- description
- 1/2 of the total number of patients will be randomized into the suture group (excision wound will be closed with suture), the intervention is the method of closure (sutures or staples)
- interventionNames
- Other: Wound Closure with sutures vs staples
- type
- OTHER
- label
- Staples group
- description
- 1/2 of the total number of patients will be randomized into the staples group (excision wound will be closed with staples), the intervention is the method of closure (sutures or staples)
- interventionNames
- Other: Wound Closure with sutures vs staples
Primary outcomes (6)
- measure
- Scored cosmetic appearance by blinded physician
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 and over * Willing to return to KU for follow up clinic visits on at least 2 occasions * Lesion location on high tension area as defined by: back, shoulder, scapula, elbow, scalp * Incisions between the lengths of 3cm to 12 cm * Skin pathology as defined by BCC, SCC, Melanoma * No known history of keloid or excessive scar formation * No known contraindication or skin sensitivity to suture or staple material * No contraindication to lidocaine with epinephrine Exclusion Criteria: * \<18 years old * Non english speaking * Needs surrogate decision maker
References
Publications (2)
- BACKGROUNDSharma C, Verma A, Soni A, Thusoo M, Mahajan VK, Verma S. A randomized controlled trial comparing cosmetic outcome after skin closure with 'staples' or 'subcuticular sutures' in emergency cesarean section. Arch Gynecol Obstet. 2014 Oct;290(4):655-9. doi: 10.1007/s00404-014-3274-9. Epub 2014 May 11. PMID 24816689
- BACKGROUNDFayssoux K, Mahmood R, Grindle J, Nass S. Staples vs. Sutures After Cesarean Delivery. Am Fam Physician. 2018 Jul 1;98(1):50. No abstract available. PMID 30215963