Wound Closure TechniqueNCT07633977
Comparison of Cosmetic Outcome and Patient Satisfaction Between Staples and Suture Technique for Wound Closure Following Upper Limb Surgeries
A study testing Staples and Sutures in people with Wound Closure Technique and Wound Dehiscence, Surgical, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Closure Technique, Wound Dehiscence, Surgical
- What is being tested?
- Staples and Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNepal
- Study dates
- 1 Nov 2022to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Open upper limb fracture
- Known metal allergy(nickel, titanium)
- Active infection
- Malignant tumor excision
- Tendon repair
- Closed Reduction Percutaneous Pinning
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Dhulikhel Hospital, Kathmandu University Hospital
Dhulikhel, Bagmati, 45200
About this study
Official title: A Comparative Study of Wound Outcome and Patient Satisfaction Between Incisions Closed With Staples and Sutures Following Elective Upper Limb Orthopedic Surgeries
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.
Read more
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
- Being tested
- Staples, Sutures
- Keywords
- Surgical wound, Staples, Sutures, Postoperative pain, Wound infection
- Medical subject headings
- Surgical Wound Dehiscence, Surgical Wound, Pain, Postoperative, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StaplesProcedure or surgery
Following completion of the upper limb surgical procedure, skin closure is performed using sterile surgical skin staples under aseptic precautions.
SuturesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Skin Closure with Suture Group | Active comparator | Not described Receives: Procedure: Sutures |
| Skin Closure with Staple Group | Experimental | Not described Receives: Procedure: Staples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
Postoperative Pain Assessed by 5-Point Pain Scale
Postoperative pain at the wound site will be assessed during follow-up visits using a 5-point pain scale ranging from 1 to 5, where 1 indicates no pain and 5 indicates very severe pain. Lower scores indicate less postoperative pain.
Measured: 1 year
Surgical Site Infection
Surgical site infection will be assessed clinically during postoperative follow-up visits on day 2, day 7, day 14, and day 30. Infection will be reported as presence or absence of clinical signs including redness, swelling, discharge, or wound tenderness.
Measured: 1 year
Length of Hospital Stay
Length of hospital stay will be measured in days from the date of surgery until discharge from hospital. Shorter hospital stay indicates improved postoperative recovery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Nov 2022
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wound Closure TechniqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohit Shrestha, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633977
- Sponsor's protocol ID
- 30/23
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10167360Edlich 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.
PubMed 4267743Orlinsky 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.
PubMed 7832962Meiring 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.
PubMed 7112304Chaudhary, 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Wound Outcome and Patient Satisfaction Between Incisions Closed With Staples and Sutures Following Elective Upper Limb Orthopedic Surgeries
- ClinicalTrials.gov ID
- NCT07633977
- Acronym / sponsor ID
- 30/23
- Keywords
- Surgical wound, Staples, Sutures, Postoperative pain, Wound infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Closure with Suture Group | Active comparator | Procedure: Sutures |
| Skin Closure with Staple Group | Experimental | Procedure: Staples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Open upper limb fracture
- Known metal allergy(nickel, titanium)
- Active infection
- Malignant tumor excision
- Tendon repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StaplesFollowing completion of the upper limb surgical procedure, skin closure is performed using sterile surgical skin staples under aseptic precautions. | Procedure or surgery | Skin Closure with Staple Group |
| SuturesFollowing 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. | Procedure or surgery | Skin Closure with Suture Group |
Primary outcome
Cosmetic Outcome Assessed by 5-Point Visual Analogue Scale (VAS)
Time frame: 1 year
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.
Patient Satisfaction Assessed by 5-Point Satisfaction Scale
Time frame: 1 year
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.
3 secondary outcomes
Postoperative Pain Assessed by 5-Point Pain Scale
Time frame: 1 year
Surgical Site Infection
Time frame: 1 year
Length of Hospital Stay
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Results publication: PubMed 10167360Rodeheaver 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.
- Results publication: PubMed 4267743Edlich 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.
- Results publication: PubMed 7832962Orlinsky 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.
- Results publication: PubMed 7112304Meiring 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.
- Results publicationChaudhary, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staples and Sutures in people with Wound Closure Technique and Wound Dehiscence, Surgical, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic Outcome Assessed by 5-Point Visual Analogue Scale (VAS) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07633977, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.