NCT07633977

Brief Summary

Surgical wound closure is an essential component of postoperative care that influences wound healing, infection rates, cosmetic appearance, and patient satisfaction. Sutures are conventionally used for skin closure following orthopedic procedures; however, surgical staples have gained popularity because of their rapid application, secure fixation, and potentially superior cosmetic outcomes. Despite their widespread use, there remains limited evidence comparing cosmetic outcomes and patient satisfaction between staple and suture techniques in upper limb surgeries in the local setting. This study aims to compare the cosmetic outcome and patient satisfaction between staples and sutures for wound closure following upper limb surgeries at Dhulikhel Hospital. Secondary objectives include comparing wound infection rates and duration of hospital stay between the two techniques. A prospective comparative study is conducted among adult patients undergoing upper limb surgeries. Patients fulfilling the inclusion and exclusion criteria are recruited consecutively during the study period. Following completion of surgery, wound closure is performed either with interrupted sutures or surgical staples according to the operative plan. Wounds are to be evaluated on postoperative day 2, day 7, and day 14, with further follow-up at 30 days and 6 weeks. Cosmetic outcome and patient satisfaction are assessed using a 5-point Visual Analogue Scale (VAS). Pain assessment, wound complications including infection, and duration of hospital stay are also documented and compared between the two groups. The findings of this study can help identify the optimal skin closure method for upper limb surgeries and contribute to improved postoperative outcomes and patient satisfaction. HYPOTHESES OF THE STUDY Null hypothesis (Ho): there is no difference in cosmetic outcome and patient satisfaction between sutures and staple technique for wound closure following upper limb surgeries. Alternative hypothesis (H1): there is difference in cosmetic outcome and patient satisfaction between sutures and staple technique for wound closure following upper limb surgeries Hence, Ho : (Cosmetic and Patient satisfaction score) in Suture group = Cosmetic and Patient satisfaction score) in Staples group H1 : (Cosmetic and Patient satisfaction score) in Suture group ≠ (Cosmetic and Patient satisfaction score) in Staples group

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 24, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Surgical woundStaplesSuturesPostoperative painWound infection

Outcome Measures

Primary Outcomes (2)

  • Cosmetic Outcome Assessed by 5-Point Visual Analogue Scale (VAS)

    Cosmetic outcome following wound closure with staples or sutures will be assessed at 30 days and 6 weeks using a 5-point Visual Analogue Scale (VAS). The scale ranges from 1 to 5, where 1 indicates excellent cosmetic appearance and 5 indicates very poor cosmetic appearance. Lower scores indicate better cosmetic outcome.

    1 year

  • Patient Satisfaction Assessed by 5-Point Satisfaction Scale

    Patient satisfaction regarding wound closure will be assessed at 30 days and 6 weeks using a 5-point satisfaction scale. The scale ranges from 1 to 5, where 1 indicates extremely satisfied and 5 indicates extremely dissatisfied. Lower scores indicate greater patient satisfaction.

    1 year

Secondary Outcomes (3)

  • Postoperative Pain Assessed by 5-Point Pain Scale

    1 year

  • Surgical Site Infection

    1 year

  • Length of Hospital Stay

    1 year

Study Arms (2)

Skin Closure with Suture Group

ACTIVE COMPARATOR
Procedure: Sutures

Skin Closure with Staple Group

EXPERIMENTAL
Procedure: Staples

Interventions

StaplesPROCEDURE

Following completion of the upper limb surgical procedure, skin closure is performed using sterile surgical skin staples under aseptic precautions.

Skin Closure with Staple Group
SuturesPROCEDURE

Following completion of the upper limb surgical procedure, skin closure is performed using interrupted non-absorbable skin sutures under aseptic precautions. Skin closure is mattress as it allows for inversion or eversion of the repaired tissue, greater repair strength, and provides a greater area of soft tissue apposition to bone.

Skin Closure with Suture Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient (\> 18 years and above)
  • Any wound more than two centimeters in length
  • All closed fracture of upper limb requiring open reduction and internal fixations
  • All implant removal and benign tumor excision of upper limb

You may not qualify if:

  • Open upper limb fracture
  • Known metal allergy(nickel, titanium)
  • Active infection
  • Malignant tumor excision
  • Tendon repair
  • Closed Reduction Percutaneous Pinning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Bagmati, 45200, Nepal

Location

Related Publications (5)

  • Rodeheaver GT, Beltran KA, Green CW, Faulkner BC, Stiles BM, Stanimir GW, Traeland H, Fried GM, Brown HC, Edlich RF. Biomechanical and clinical performance of a new synthetic monofilament absorbable suture. J Long Term Eff Med Implants. 1996;6(3-4):181-98.

  • Edlich RF, Panek PH, Rodeheaver GT, Turnbull VG, Kurtz LD, Edgerton MT. Physical and chemical configuration of sutures in the development of surgical infection. Ann Surg. 1973 Jun;177(6):679-88. doi: 10.1097/00000658-197306000-00006. No abstract available.

  • Orlinsky M, Goldberg RM, Chan L, Puertos A, Slajer HL. Cost analysis of stapling versus suturing for skin closure. Am J Emerg Med. 1995 Jan;13(1):77-81. doi: 10.1016/0735-6757(95)90248-1.

  • Meiring L, Cilliers K, Barry R, Nel CJ. A comparison of a disposable skin stapler and nylon sutures for wound closure. S Afr Med J. 1982 Sep 4;62(11):371-2.

  • Chaudhary, P., Shrestha, B. P., Khanal, G. K., Rijal, R., & Maharjan, R. (2017). Randomized controlled trial comparing outcome of use of staples and nylon sutures for closure in elective orthopedic surgery. Health Renaissance, 13(3), 137-143. https://doi.org/10.3126/hren.v13i3.17937

    RESULT

MeSH Terms

Conditions

Surgical Wound DehiscenceSurgical WoundPain, PostoperativeWound Infection

Interventions

Sutures

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsInfections

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 8, 2026

Study Start

November 1, 2022

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

June 8, 2026

Record last verified: 2026-05

Locations