Comparison of Cosmetic Outcome and Patient Satisfaction Between Staples and Suture Technique for Wound Closure Following Upper Limb Surgeries
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.
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
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Bagmati
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Dhulikhel, Bagmati, Népal, 45200
- Dhulikhel Hospital, Kathmandu University Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Open upper limb fracture
- Known metal allergy(nickel, titanium)
- Active infection
- Malignant tumor excision
- Tendon repair
- Closed Reduction Percutaneous Pinning
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Skin Closure with Suture Group
|
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.
|
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Expérimental: Skin Closure with Staple Group
|
Following completion of the upper limb surgical procedure, skin closure is performed using sterile surgical skin staples under aseptic precautions.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cosmetic Outcome Assessed by 5-Point Visual Analogue Scale (VAS)
Délai: 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.
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1 year
|
|
Patient Satisfaction Assessed by 5-Point Satisfaction Scale
Délai: 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.
|
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative Pain Assessed by 5-Point Pain Scale
Délai: 1 year
|
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.
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1 year
|
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Surgical Site Infection
Délai: 1 year
|
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.
|
1 year
|
|
Length of Hospital Stay
Délai: 1 year
|
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.
|
1 year
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- La douleur
- Manifestations neurologiques
- Blessures et Blessures
- Complications postopératoires
- Processus pathologiques
- Infections
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Plaie chirurgicale
- Douleur, Postopératoire
- Infection de la plaie
- Déhiscence chirurgicale des plaies
- Équipement chirurgical
- Équipement et fournitures
- Dispositifs de fixation chirurgicale
- Sutures
Autres numéros d'identification d'étude
- 30/23
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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